Z-0542-2009

Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN...

Name: Z-0542-2009 Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN...
Creator: Roche Diagnostics Corp.
Published: 2008-09-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2008-09-15 / Terminated / root cause: packaging

FDA source

Roche Diagnostics Corp. began a recall of Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro... on 2008-09-15. The reason FDA records is "Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0542-2009
Status: Terminated
Initiated: 2008-09-15
Posted: 2009-01-06
Terminated: 2009-12-01
Recalling firm: Roche Diagnostics GmbH
Product: Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees were notified by letter dated 9/15/08, which provided a work-around for them to use until the problem can be permanently resolved. The letter was entitled "URGENT MEDICAL DEVICE CORRECTION." For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.
Quantity in commerce: 7909
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: 60258801, 60258601, 60145701, 60145601, 69921901, 69921801, 69786201, 69922001, 69786101, 69676101, 69509701, 69431901, 69357601, 69342001, 69246501, 68966601 and 68871601.

Product code JIX

K060373Class IICobas 6000 Series SystemRoche Diagnostics / cleared 2006-03-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)