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Terminated

Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.

FDA Recall Z-0098-06 · 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.

K030845COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTINGRoche Diagnostics Corp. · 2003-05-22K021190PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422Roche Diagnostics Corp. · 2002-10-25K962571COAGUCHEK PST SYSTEMBoehringer Mannheim Corp. · 1997-04-22

Official Source

View FDA Recall →

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

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