Z-0646-2007

Thyrotest TSH POC Rapid membrane test. In vitro diagnostic

Name: Z-0646-2007 Thyrotest TSH POC Rapid membrane test. In vitro diagnostic
Creator: ThyroTec Inc
Published: 2007-01-24
License: https://open.fda.gov/license/

ThyroTec Inc / initiated 2007-01-24 / Terminated

FDA source

ThyroTec Inc began a recall of Thyrotest TSH POC Rapid membrane test. In vitro diagnostic on 2007-01-24. The reason FDA records is "Positive control showed little or no positive line". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0646-2007
Status: Terminated
Initiated: 2007-01-24
Posted: 2007-03-22
Terminated: 2007-06-04
Recalling firm: ThyroTec Inc
Product: Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Positive control showed little or no positive line.
FDA root cause: Other
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.
Quantity in commerce: 484 units
Distribution: Nationwide.
Product codes and lots: Product Code 1020, Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.

Product code JLW

K030912Class IIThyro TestThryotec / cleared 2003-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)