Ortho Clinical Diagnostics Recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.
What this means for you
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 defect (swapped reagents) can lead to false negative results for a serious pathogen (SARS-CoV-2), fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs (Catalog number 6199919, UDI 10758750033355). The affected lots are 0010 through 0013, and 2,349 sales units were distributed worldwide and nationwide in the United States. The product is intended for in vitro diagnostic and Laboratory Professional use only under emergency authorization.
The recall was initiated because reagent bottles may be swapped within the reagent pack. This defect may lead to false negative results or delayed results due to calibration failures or quality control failures.
This recall affects laboratories and healthcare facilities that use the VITROS Anti-SARS-CoV-2 IgG Reagent Pack for testing. Consumers and patients should contact their healthcare provider or laboratory if they have had recent tests using this product to discuss the potential impact on their results.
The recalled product
- Product
- VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 2,349
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 - 0013
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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