VITROS Anti-SARS-CoV-2 Total Reagent recall
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro…
Why was VITROS Anti-SARS-CoV-2 Total Reagent recalled?
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
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 0010-0037
- Product
- VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro…
- Recalling firm
- Ortho Clinical Diagnostics
- Quantity
- 47,271 sales units
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- August 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)