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Terminated

Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001.

FDA Recall Z-0099-06 · Posted 2005-10-28

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeGJS
Date Initiated2005-03-28
Date Terminated2006-04-06
Product Quantityunknown.

Reason for Recall

Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

Firm Action

Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974569COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTINGBoehringer Mannheim Corp. · 1998-01-09K952625COAGUCHEK SYSTEMBoehringer Mannheim Corp. · 1995-11-21K942884COAGUCHEK SYSTEMBoehringer Mannheim Corp. · 1995-05-11K930454BOEHRINGER MANNHEIM COAGUCHEK SYSTEMBoehringer Mannheim Corp. · 1993-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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