Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended recall
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated…
Why was Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended recalled?
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
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-DI :10758750034413. All expired, in-date and future released lots
- Product
- Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated…
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 20858
- Distribution
- Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
- Recall date
- July 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)