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Nasopharyngeal sample collection tray for COVID-19 testing… recallZ-1277-2022 · American Contract Systems, Inc. · initiated May 2, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.

Recall details

Recall number
Z-1277-2022
Status
Open, Classified
Initiated by the company
May 2, 2022
Posted by the FDA
Jul 1, 2022
Recalling firm
American Contract Systems, Inc.
Quantity
274,400 kits total
Product code
JSM
Distribution
US distribution in the state of Minnesota.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 90324).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page