COVID Test Kits Recalled for Incorrect Labeling and Device Incompatibility
American Contract Systems is recalling COVID test kits incorrectly labeled for SARS-CoV-2 testing use. The 39,575 kits distributed in Pennsylvania should not be used with COVID devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a labeling error on a medical device. No illnesses or injuries have been reported. It qualifies as High severity as a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
American Contract Systems, Inc. is recalling 39,575 COVID Test Kits (Nonsterile) due to labeling issues. The kits are labeled for use with COVID testing but should not be used with SARS-CoV-2 devices according to the manufacturer.
The affected lots are: Product Code AHCV18A (Lots 980221 and 974221, expiring 01/20/2023 and 01/25/2023 respectively) and Product Code AHCV18B (Lots 868221 and 842221, expiring 05/31/2023). These kits were distributed to a single customer in Pennsylvania.
Customers who received these kits should stop using them immediately and contact American Contract Systems, Inc. for further guidance. These kits should not be used with any SARS-CoV-2 testing devices.
The recalled product
- Product
- COVID Test Kit Nonsterile
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — COVID Testing
- Affected units
- 39,575
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 (3)
- 1) UDI-DI: Product Code: AHCV18A
- Lots 868221 (exp. 05/31/2023)
- 842221 (exp. 05/31/2023)
Distribution
Distributed in 1 state:
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