FDA Medical Device Recalls (openFDA)
ThyroTec Inc: Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
- Recall number
- Z-0646-2007
- Recalling firm
- ThyroTec Inc
- Product
- Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
- Status
- Terminated
- Initiated
- 2007-01-24
- Posted
- 2007-03-22
- Terminated
- 2007-06-04
- Reason
- Positive control showed little or no positive line.
- 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
- 484 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Product Code 1020, Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.
- 510(k) numbers
- ["K030912"]
- PMA numbers
- not on file
- Product code
- JLW
- Firm FEI
- 3004844724
- Firm city
- Honey Brook
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28