Recall Z-1333-2021— Biocare Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Biocare Medical, LLC, initiated 2021-02-25, terminated 2023-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1. 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
- Biocare Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-25
- Terminated
- 2023-01-31
- Firm location
- Pacheco, CA, United States
Product description
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.