RecallRadar

FDA Device recall Z-1277-2022

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

On 2022-07-13 the FDA classified a Class I recall of Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A by American Contract Systems, citing affected products were assembled off-site by individuals who may not have been properly trained.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1277-2022
ClassificationClass I
Statusongoing
Initiated2022-05-02
Published2022-07-13
Last updated2026-09-13 11:56 UTC
CompanyAmerican Contract Systems
DistributionMN

Product

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Reason

Affected products were assembled off-site by individuals who may not have been properly trained.

Identifiers

code_infoUDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1277-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.