Z-0071-2023Class II

COVID Test Kit Nonsterile

Name: Z-0071-2023 COVID Test Kit Nonsterile
Creator: American Contract Systems, Inc.
Published: 2022-08-12
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2022-08-12 / Open, Classified / root cause: labeling and UDI

FDA source

American Contract Systems, Inc. began a recall of COVID Test Kit Nonsterile on 2022-08-12. FDA classified it as Class II and gives the reason as "Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0071-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-12
Posted: 2022-10-08
Recalling firm: American Contract Systems, Inc.
Product: COVID Test Kit Nonsterile
Product code: JSM Culture Media, Non-Propagating Transport
Reason for recall: Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: A customer letter dated 08/12/2022 was sent on or around 08/15/2022 to the single impacted consignee. The customer is instructed that the product cannot be used in association with SARS-CoV-2 or COVID-19 testing but instead only for general use of specimen collection. The product is to be relabeled in accordance with the recall communication letter. A Field Action Response Form is to be completed and returned to [email protected]. A second customer letter dated September 8, 2022 was sent on or around the same day to notify the consignee that 2 lots listed in this event cannot be relabeled, as they are subject to destruction from a previous recall event. Those two lots are Product #AHCV18A, lots 980221 and 974221. The consignee is requested to confirm destruction of the lots.
Quantity in commerce: 39,575 kits
Distribution: Distribution to one customer in PA only
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-08

Product code JSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)