FDA-Device2021-04-07Class II
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Biocare Medical, LLC
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.
Sold states
US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands
Affected count
72 units
Manufactured in
60 Berry Dr, Pacheco, CA, United States
Products
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1333-2021Don't want to check this manually?
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