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U.S. Department of Health and Human Services

Class 1 Device Recall COVID Test Kit Nonsterile

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  Class 1 Device Recall COVID Test Kit Nonsterile see related information
Date Initiated by Firm May 02, 2022
Date Posted July 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1277-2022
Recall Event ID 90324
Product Classification Culture media, non-propagating transport - Product Code JSM
Product Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Code Information UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
2610 Ne Industrial Dr Ste 220
Kansas City MO 64117-2648
For Additional Information Contact Angela L. Bunn
479-364-7174
Manufacturer Reason
for Recall		 Affected products were assembled off-site by individuals who may not have been properly trained.
FDA Determined
Cause 2		 Process control
Action On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.
Quantity in Commerce 274,400 kits total
Distribution US distribution in the state of Minnesota.
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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