Trinity biotech Captia recall
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use…
Why was Trinity biotech Captia recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 033, expiry date 30 November 2014
- Product
- Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use…
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Quantity
- Domestic: 9 kits; Foreign: 26 kits
- Distribution
- New York, Florida, Utah, and California plus foreign distribution to Spain and France
- Recall date
- December 24, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)