Trinity Biotech Captia Measles IgM recall
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Why was Trinity Biotech Captia Measles IgM recalled?
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
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 Number 2326060-043, Expiration Date 31 May 2017
- Product
- Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Quantity
- US: 6 kits, Foreign: 50 kits
- Distribution
- Distribution to US nationwide including California, and China (Hong Kong).
- Recall date
- September 21, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)