Company: Biocare Medical, LLC
Date of Enforcement Report: 4/7/2021
Class II
PRODUCT
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: ” Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Recall Number: Z-1333-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Biocare Medical, LLC on 2/25/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
U.S. Nationwide and International