Z-2771-2020 Class II Terminated
FDA device recall Z-2771-2020 was initiated by Ortho Clinical Diagnostics on July 17, 2020 and is designated Class II. 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. The recall status is terminated (terminated July 16, 2021). Affected quantity: 2349 sales units.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- July 17, 2020
- Termination Date
- July 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2349 sales units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
Lots 0010 - 0013