Z-0667-03

COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345...

Name: Z-0667-03 COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345...
Creator: Roche Diagnostics Corp.
Published: 2003-02-13
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-02-13 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corp. began a recall of COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345 on 2003-02-13. The reason FDA records is "After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0667-03
Status: Terminated
Initiated: 2003-02-13
Posted: 2003-03-21
Terminated: 2003-03-20
Recalling firm: Roche Diagnostics GmbH
Product: COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345
Reason for recall: After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 1905
Distribution: United States
Product codes and lots: lot 639106

K951595Class IIRoche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. / cleared 1995-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)