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.
Reported: August 19, 2020 Initiated: July 17, 2020 #Z-2771-2020
Product Description
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.
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.
Details
- Recalling Firm
- Ortho Clinical Diagnostics
- Units Affected
- 2349 sales units
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ortho Clinical Diagnostics. Units affected: 2349 sales units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2020. Severity: Moderate. Recall number: Z-2771-2020.
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