ThyroTec Inc Thyrotest TSH POC Rapid membrane test. In vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
Brand
ThyroTec Inc
Lot Codes / Batch Numbers
Product Code 1020, Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.
Products Sold
Product Code 1020, Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.
ThyroTec Inc is recalling Thyrotest TSH POC Rapid membrane test. In vitro diagnostic. due to Positive control showed little or no positive line.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Positive control showed little or no positive line.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026