VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG recall
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600…
Why was VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG recalled?
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
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: 0040(*and potentially future lots) UDI: 10758750034475 Exp. Date: 19NOV2021
- Product
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600…
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Quantity
- US: 64 OUS: 200
- Distribution
- Worldwide Distribution: US (Nationwide) in states of: AL, AR, AZ, CA, CO, DC, FL, ID, KS, KY, LA, ME, MI, MS, MO, NY, TN, TX and WV; and OUS (Foreign) in countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, and The Netherlands.
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)