Summary
The FDA issued a Class II for COVID Test Kit Nonsterile by American Contract Systems, Inc.. Reason: Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device..
Details
Source
Device Recall
External ID
Z-0071-2023
Action Date
2022-10-19
Status
Ongoing
Category
device
Product Description
COVID Test Kit Nonsterile
Lot/Code Info: 1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)
Quantity Affected: 39,575 kits
Reason for Recall
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Distribution
Distribution to one customer in PA only
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-12
Company
Bloomington, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems, Inc. have FDA actions?
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0071-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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