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Terminated

CoaguChek PT test strips, sold in 12 pack.

FDA Recall Z-0720-03 · Posted 2003-04-10

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJPA
Date Initiated2003-02-20
Date Terminated2003-11-10
Product Quantity11412 containers

Reason for Recall

Discrepancy between INR and the % Quick displayed on the meter.

Firm Action

Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.

Root Cause

Other

Distribution Pattern

Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974569COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTINGBoehringer Mannheim Corp. · 1998-01-09

Official Source

View FDA Recall →

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

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