Class 1 Device Recall COVID Test Kit Nonsterile

• Date Initiated by Firm: May 02, 2022
• Date Posted: July 01, 2022
• Recall Status: Open, 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: 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.