FDAFebruary 25, 2021device
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations.
What to do
FDA enforcement status: Terminated
Brands named
biocare medicalbiocare
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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