FDA product code · Clinical Chemistry
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
Product code JJE covers Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I device regulated under 21 CFR 862.2160. FDA has cleared 208 devices in this code. Median review time across the 208 most recent decisions is 53 days. openFDA lists 559 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 862.2160
- Review panel
- Clinical Chemistry
- Clearances
- 208
What is happening in JJE right now?
JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use) has one finding. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1476-2026, Z-1025-2026, Z-1026-2026, Z-0961-2026, Z-0889-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1476-2026, Z-1025-2026, Z-1026-2026, Z-0961-2026, Z-0889-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JJE?
FDA has cleared 208 devices under product code JJE since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Horiba, Ltd. | |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | Carolina Liquid Chemistries Corp. | |
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | Jas Diagnostics, Inc. | |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | Randox Laboratories, Ltd. | |
| K130276 | DIMENSION EXL WITH LM SYSTEM | Siemens Healthcare Diagnostics, Inc. | |
| K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | |
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM | Siemens Healthcare Diagnostics | |
| K110035 | INDIKO | Thermofisher Scientific OY | |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | Teco Diagnostics | |
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM | Ortho-Clinical Diagnostics, Inc. |
How long does FDA review take for JJE?
The median FDA review time for JJE is 53 days, measured across the 208 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JJE?
openFDA lists 559 recall records against product code JJE. A recall record covers one firm's corrective action and may span many device lots.
Z-1476-2026Open, ClassifiedRoche Diagnostics Operations, Inc.
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
Z-1025-2026Open, ClassifiedBeckman Coulter, Inc.
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Z-1026-2026Open, ClassifiedBeckman Coulter, Inc.
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Z-0961-2026Open, ClassifiedAbbott Laboratories, Inc.
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
Z-0889-2026Open, ClassifiedBeckman Coulter, Inc.
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Showing the 5 most recently initiated of 559. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JJE?
MAUDE holds 12,531 adverse-event reports naming product code JJE, 2,968 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JJE unusual?
One month sits above JJE's own expected range: 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 335 | Insufficient history | No expected range — too little history | |
| 308 | Insufficient history | No expected range — too little history | |
| 348 | Insufficient history | No expected range — too little history | |
| 298 | Insufficient history | No expected range — too little history | |
| 304 | Insufficient history | No expected range — too little history | |
| 297 | Insufficient history | No expected range — too little history | |
| 238 | Insufficient history | No expected range — too little history | |
| 304 | Insufficient history | No expected range — too little history | |
| 279 | Insufficient history | No expected range — too little history | |
| 299 | Insufficient history | No expected range — too little history | |
| 359 | Insufficient history | No expected range — too little history | |
| 328 | Insufficient history | No expected range — too little history | |
| 335 | Insufficient history | No expected range — too little history | |
| 367 | Insufficient history | No expected range — too little history | |
| 281 | Insufficient history | No expected range — too little history | |
| 356 | Insufficient history | No expected range — too little history | |
| 391 | Insufficient history | No expected range — too little history | |
| 344 | Insufficient history | No expected range — too little history | |
| 397 | Insufficient history | No expected range — too little history | |
| 359 | Insufficient history | No expected range — too little history | |
| 405 | Insufficient history | No expected range — too little history | |
| 316 | 295–385 | Within expected (295–385) | |
| 289 | 257–324 | Within expected (257–324) | |
| 350 | 289–359 | Within expected (289–359) | |
| 386 | 304–383 | Above expected (304–383) | |
| 353 | 288–380 | Within expected (288–380) | |
| 351 | 300–403 | Within expected (300–403) | |
| 392 | 482–624 | Below expected (482–624) | |
| 324 | 303–461 | Within expected (303–461) | |
| 399 | 290–477 | Within expected (290–477) | |
| 377 | 293–478 | Within expected (293–478) | |
| 352 | 261–430 | Within expected (261–430) | |
| 436 | 291–479 | Within expected (291–479) | |
| 324 | 353–569 | Below expected (353–569) | |
| 404 | 242–470 | Within expected (242–470) | |
| 452 | 281–532 | Within expected (281–532) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in JJE.
What are the predicate devices in JJE?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JJE?
Across the 208 most recent decisions, these applicants filed most often in JJE.
| Applicant | Recent clearances |
|---|---|
| Eastman Kodak Company | 18 |
| Boehringer Mannheim Corp. | 16 |
| Abbott Laboratories | 13 |
| Beckman Instruments, Inc. | 9 |
| Ciba Corning Diagnostics Corp. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JJE
Get an email the morning anything changes in JJE — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.