Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD
FDA device recall Z-0819-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Reason for recall
- Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
- Action taken
- Recall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LIP
- Quantity affected
- Domestic: 9 kits; Foreign: 26 kits
- Distribution
- New York, Florida, Utah, and California plus foreign distribution to Spain and France
- Date initiated
- 2014-11-17
- Date posted
- 2014-12-16
- Date terminated
- 2016-05-24
- Location
- Jamestown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPTIA(R) SYPHILIS M, MODIFICATION (K904524) | Mercia Diagnostics , Ltd. | 1990-12-26 |