CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
FDA Recall Z-0737-2007 · Posted 2007-04-11
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Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeGJS
Date Initiated2007-02-28
Date Terminated2007-06-13
Product Quantity10
Reason for Recall
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
Firm Action
All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
Root Cause
Other
Distribution Pattern
Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K994349COAGUCHEK S SYSTEM, MODEL 2138280Roche Diagnostics Corp. · 2000-09-06K974569COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTINGBoehringer Mannheim Corp. · 1998-01-09K962571COAGUCHEK PST SYSTEMBoehringer Mannheim Corp. · 1997-04-22K930454BOEHRINGER 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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