VITROS Immunodiagnostic Products TT4 Reagent Pack recall
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Why was VITROS Immunodiagnostic Products TT4 Reagent Pack recalled?
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
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?
UDI: 10758750005147; Lot Number: 2340
- Product
- VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
- Recalling firm
- Ortho Clinical Diagnostics
- Quantity
- 3181
- Distribution
- US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.
- Recall date
- May 6, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)