Recall Z-2770-2020— Ortho Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho Clinical Diagnostics, initiated 2020-07-17, terminated 2021-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.. Reason: 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..
- Recalling firm
- Ortho Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-17
- Terminated
- 2021-07-16
- Firm location
- Rochester, NY, United States
Product description
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.