Reported Apr 7, 2021 · Terminated
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL…
Biocare Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocare Medical, LLC · 60 Berry Dr · Pacheco, CA · 94553-5601
Is this the product you have?
- BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument
- Ref"
- Model NumberIPS0001US and IPS0001INTL containing software version 3.5.3.1
- Lot codes and dates
- Affected US Serial Numbers
67 of 67 codes
BCIP01-0021BCIP01-0033BCIP01-0090BCIP01-0106BCIP01-0112BCIP01-0148BCIP01-0151BCIP01-0187BCIP01-0189BCIP01-0198BCIP01-0201BCIP01-0216BCIP01-0221BCIP01-0249BCIP01-0262BCIP01-0265BCIP01-0266BCIP01-0268BCIP01-0279BCIP01-0285BCIP01-0307BCIP01-0314BCIP01-0319BCIP01-0328BCIP01-0341BCIP01-0346BCIP01-0354BCIP01-0386BCIP01-0387BCIP01-0388BCIP01-0390BCIP01-0395BCIP01-0396BCIP01-0413BCIP01-0426BCIP01-0430BCIP01-0431BCIP01-0432BCIP01-0434BCIP01-0443BCIP01-0450BCIP01-0463BCIP01-0464BCIP01-0467BCIP01-0482BCIP01-0484BCIP01-0487BCIP01-0491BCIP01-0492BCIP01-0495BCIP01-0500BCIP01-0502BCIP01-0508BCIP01-0517BCIP01-0526BCIP01-0534BCIP01-0543BCIP01-0545BCIP01-0546BCIP01-0550
- BCIP01-0573 Affected OUS serial numbers
BCIP01-0454BCIP01-0515BCIP01-0538BCIP01-0556
- Affected US Serial Numbers
- Amount recalled
- 72 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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