Z-1277-2022Class I

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312...

Name: Z-1277-2022 Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312...
Creator: American Contract Systems, Inc.
Published: 2022-05-02
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2022-05-02 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems, Inc. began a recall of Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A on 2022-05-02. FDA classified it as Class I and gives the reason as "Affected products were assembled off-site by individuals who may not have been properly trained". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1277-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-05-02
Posted: 2022-07-01
Recalling firm: American Contract Systems, Inc.
Product: Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Product code: JSM Culture Media, Non-Propagating Transport
Reason for recall: Affected products were assembled off-site by individuals who may not have been properly trained.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.
Quantity in commerce: 274,400 kits total
Distribution: US distribution in the state of Minnesota.
Product codes and lots: UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1277-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-01
Z-1277-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-01

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)