VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total recall
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV)…
Why was VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total recalled?
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.
- Product
- VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV)…
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 256 units
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
- Recall date
- April 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)