American Contract Systems' COVID-19 test recall gets Class I label from FDA

Dive Brief:

American Contract Systems is recalling COVID-19 test kits and urine kits due to potential assembly issues. The Food and Drug Administration has labeled the recall of both products as Class I, the most severe recall label from the agency.
ACS, which was bought by Owens & Minor late last year, initiated the recall after learning that the “affected products were assembled off-site by individuals who may not have been properly trained.” An FDA spokesperson said in an emailed statement that the products are part of the same recall event and each device type has its own recall number.
Customers were notified to destroy or discard affected kits, according to the FDA. The agency's database entries for the recall of COVID-19 test and urine kits both state that 274,400 products are affected.

Dive Insight:

The ACS recall is the latest in a string of COVID-19 test recalls. SML Distribution recalled over 209,000 COVID-19 rapid antigen test kits because they were not allowed to be distributed in the U.S., and Celltrion has had both Class I and II recalls for over 1 million coronavirus tests. Acon Laboratories and SD Biosensor have also recalled COVID-19 tests due to the products being illegally distributed in or imported into the U.S.

ACS is a Minneapolis-based business that provides packaging and sterilization services to support the custom procedure tray programs of customers such as hospitals and surgery centers. In January 2021, ACS created the device record for a COVID-19 test kit. The kit was exempt from premarket submission and not packed as sterile.

The device record was among the only publicly available evidence of ACS' work on the COVID-19 test kit prior to the release of details of the recall.

Information remains limited, with the FDA notice stating only that the recall relates to the training of workers who assembled the kits off-site, and will lead to the destruction or discarding of the kits. The notice said that “the customer” has been notified about the recall, although it offered no specific information about how purchasers of kits would be informed.

The FDA used the same text to describe the recall of clean catch urine kits. Both database entries list the exact same number of kits affected.

The Class I label is the latest in a series of regulatory actions facing ACS. In 2019, the FDA sent ACS a warning letter after finding its Houston, Texas, facility was not compliant with good manufacturing practices. The warning letter described the failure to adequately validate sterilization operations. ACS received a warning letter related to a Pennsylvania facility in 2018.

This year, the FDA inspected an ACS facility in Kansas City, Missouri, and reportedly issued a Form 483 in relation to lax validations and “ineffective” corrective and preventive actions.