COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400… recallZ-0667-03 · Roche Diagnostics Corp. · initiated Feb 13, 2003
Terminated All recalls posted in March 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.
FDA root cause category: Other
What the company is doing
An urgent product removal bulletin dated 2/14/03 was sent to each affected customer advising them to discontinue use of this lot, to discard any product on hand, and to contact Roche for replacement.
Recall details
- Recall number
- Z-0667-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 13, 2003
- Posted by the FDA
- Mar 21, 2003
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 1905
- FDA submissions
- K951595
- Distribution
- United States
Product description
COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345
Code information (models, lots, serial numbers)
lot 639106
Other devices under the same FDA submission
11 devices cleared under K951595 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Creatinine Jaffe Gen.2 08057532190Roche Diagnostics GmbH · ALKALINE PICRATE, COLORIMETRY, CREATININE17 reports
- Creatinine Jaff Gen2 6407137190Roche Diagnostics GmbH · ALKALINE PICRATE, COLORIMETRY, CREATININE13 reports
- Total Protein Gen2 3183734190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN11 reports
- Phosphate (Inorganic) ver.2 03183793122Roche Diagnostics GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus11 reports
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 20764949322Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot6 reports
- Ethanol Gen2 3183777190Roche Diagnostics GmbH · ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD5 reports
- Total Protein Gen2 5171385190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN5 reports
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 5850819190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot4 reports
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation 4467493190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot3 reports
- Ethanol Gen.2 08057630190Roche Diagnostics GmbH · ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD2 reports
- Ethanol Gen.2 08445672190Roche Diagnostics GmbH · ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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