FDA (Devices) recall action 90324
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Affected products were assembled off-site by individuals who may not have been properly trained.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.
American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.