Recall – Lab automated staining instrument with unintended movement and speed

Company: Biocare Medical, LLC
Date of Enforcement Report: 4/7/2021
Class II


BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: ” Model Number:IPS0001US and IPS0001INTL containing software version

Recall Number: Z-1333-2021


Their is a potential that the automated staining instrument with software version 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.


Biocare Medical, LLC on 2/25/2021. Voluntary:  Firm Initiated recall is ongoing.


72 units


U.S. Nationwide and International

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Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.