Z-0100-06

Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001

Name: Z-0100-06 Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001
Creator: Roche Diagnostics Corp.
Published: 2005-03-28
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-03-28 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001 on 2005-03-28. The reason FDA records is "Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0100-06
Status: Terminated
Initiated: 2005-03-28
Posted: 2005-10-28
Terminated: 2006-04-06
Recalling firm: Roche Diagnostics GmbH
Product: Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.
Product code: GJS Test, Time, Prothrombin
Reason for recall: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
FDA root cause: Other
Action: Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
Quantity in commerce: unknown.
Distribution: Nationwide.
Product codes and lots: All lots.

Product code GJS

K994349Class IICoaguchek S System, Model 2138280Roche Diagnostics Corp. / cleared 2000-09-06

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)