COVID Test Kit Nonsterile

FDA device recall Z-0071-2023 · posted 2022-10-08 · Open, Classified

Recall details

Recalling firm

American Contract Systems, Inc.

Reason for recall

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

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

JSM

Quantity affected

39,575 kits

Distribution

Distribution to one customer in PA only

Date initiated

2022-08-12

Date posted

2022-10-08

Location

Bloomington, MN