VITROS Immunodiagnostic Products AFP Reagent Pack recall
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical…
Why was VITROS Immunodiagnostic Products AFP Reagent Pack recalled?
Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
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?
Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
- Product
- VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical…
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Quantity
- US: Lot 6471 - 282, Lot 6480 - 344
- Distribution
- US Nationwide Distribution
- Recall date
- July 20, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)