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U.S. Department of Health and Human Services

Class 2 Device Recall ACS COVID Test Kit Nonsterile

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  Class 2 Device Recall ACS COVID Test Kit Nonsterile see related information
Date Initiated by Firm August 12, 2022
Date Posted October 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-0071-2023
Recall Event ID 90800
Product Classification Culture media, non-propagating transport - Product Code JSM
Product COVID Test Kit Nonsterile
Code Information 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)
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
4801 W 81st St
Bloomington MN 55437-1111
For Additional Information Contact Angela Bunn
470-364-7147
Manufacturer Reason
for Recall		 Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
FDA Determined
Cause 2		 No Marketing Application
Action 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.
Quantity in Commerce 39,575 kits
Distribution Distribution to one customer in PA only
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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