COVID Test Kit Nonsterile
This recall is currently active, issued October 8, 2022. It was issued by American Contract Systems, Inc..
- Company
- American Contract Systems, Inc.
- Recall Initiated
- August 12, 2022
- Posted
- October 8, 2022
- Recall Number
- Z-0071-2023
- Quantity
- 39,575 kits
- Firm Location
- Bloomington, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Distribution
Distribution to one customer in PA only
Lot / Code Info
1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)
Root Cause
No Marketing Application
Action Taken
A customer letter dated 08/12/2022 was sent on or around 08/15/2022 to the single impacted consignee. The customer is instructed that the product cannot be used in association with SARS-CoV-2 or COVID-19 testing but instead only for general use of specimen collection. The product is to be relabeled in accordance with the recall communication letter. A Field Action Response Form is to be completed and returned to angela.bunn@owens-minor.com. A second customer letter dated September 8, 2022 was sent on or around the same day to notify the consignee that 2 lots listed in this event cannot be relabeled, as they are subject to destruction from a previous recall event. Those two lots are Product #AHCV18A, lots 980221 and 974221. The consignee is requested to confirm destruction of the lots.