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Terminated

CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

FDA Recall Z-0813-03 · Posted 2003-05-14

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJPA
Date Initiated2003-03-12
Date Terminated2005-02-03
Product Quantity1322

Reason for Recall

High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.

Firm Action

Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983892COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK PRoche Diagnostics/Boehringer Mannheim GmbH · 1999-04-13

Official Source

View FDA Recall →

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

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