Ortho VITROS Anti-SARS-CoV-2 Reagent Recalled for Potential False Negatives
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk diagnostic product where the hazard (false negatives) poses a significant risk of harm to patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent (Catalog number 6199922, UDI 10758750033386). The recall involves 47,271 sales units distributed worldwide and nationwide in the US. The affected lots are 0010-0037.
The recall was initiated because reagent bottles may be swapped within the reagent pack. This issue may lead to false negative results or delayed results due to calibration failures or quality control failures.
This product is for in vitro diagnostic and Laboratory Professional use only. It is intended for emergency authorization use only. Consumers and laboratory professionals should contact Ortho Clinical Diagnostics for further instructions regarding the affected units.
The recalled product
- 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.
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 47,271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 0010-0037
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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