Recalls / —

—#195858

Product

COVID Test Kit Nonsterile

FDA product code

JSM — Culture Media, Non-Propagating Transport

Device class

Class 1

Medical specialty

Microbiology

Affected 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)

Why it was recalled

Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

Root cause (FDA determination)

No Marketing Application

Action the firm took

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 angela.bunn@owens-minor.com. 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.

Recalling firm

Firm

American Contract Systems, Inc.

Address

4801 W 81st St, Bloomington, Minnesota 55437-1111

Distribution

Distribution pattern

Distribution to one customer in PA only

Timeline

Recall initiated

2022-08-12

Posted by FDA

2022-10-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #195858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.