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Terminated

Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.

FDA Recall Z-0646-2007 · Posted 2007-03-22

Recalling FirmThyroTec Inc
Recall StatusTerminated
Product CodeJLW
Date Initiated2007-01-24
Date Terminated2007-06-04
Product Quantity484 units

Reason for Recall

Positive control showed little or no positive line.

Firm Action

On 1/24/07 the recalling firm notified their only customer of the problem. On 2/5/07, the distributor issued recall letters to their customers informing of the problem and the need to destroy the kits. The kits from lot number 02106-06 were returned to the recalling firm.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030912THYRO TESTThryotec · 2003-07-25

Official Source

View FDA Recall →

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

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