COVID-19 nasopharyngeal sample collection tray recalled due to improper assembly
American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which establishes a minimum Severe rating. The manufacturing deficiency—assembly by workers who may not have been properly trained—represents a quality concern for a diagnostic medical device.
Plain-English summary
American Contract Systems, Inc. is recalling COVID TEST KIT NONSTERILE 184312, a nasopharyngeal sample collection tray used in COVID-19 testing. The recall affects 274,400 kits distributed in Minnesota, with lot numbers 721211, 672211, 657211, 994221, 980221, and 974221.
The FDA classified this as a Class I recall. The products were assembled off-site by individuals who may not have been properly trained, raising concerns about assembly quality and product integrity.
Consumers and healthcare facilities with affected kits should contact American Contract Systems, Inc. or the FDA for guidance on returns, replacements, or other next steps.
The recalled product
- Product
- Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- improper-assembly
- quality-control-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI-DI: 00191072121233 Lots: 721211
- 672211
- 657211
- 994221
- 980221
- 974221
Distribution
Distribution scope not specified by the agency.
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