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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 274,400
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
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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