Biocare Medical IntelliPath FLX Automated Staining Instrument Recall
Biocare Medical is recalling 72 IntelliPath FLX instruments due to a software defect that may cause random movement and buffer dispensing errors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of physical damage to the instrument and components, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Biocare Medical, LLC is recalling 72 units of the IntelliPath FLX Automated Staining Instrument. The affected units are Model Numbers IPS0001US and IPS0001INTL containing software version 3.5.3.1. The recall covers units distributed in the United States and internationally to Germany and the Netherlands.
The recall is due to a potential software defect that may cause the instrument to move at random speeds and in random directions across its range of motion. This malfunction could result in the instrument hitting end stops or colliding with other components on the working deck. Additionally, the defect may cause wash buffer to be dispensed in random locations.
Affected units are identified by specific serial numbers listed in the agency's structured data. Consumers and healthcare facilities should contact Biocare Medical, LLC for instructions on how to address the software issue.
The recalled product
- Product
- BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
- Manufacturer
- Biocare Medical, LLC
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Affected US Serial Numbers: BCIP01-0021
- BCIP01-0033
- BCIP01-0090
- BCIP01-0106
- BCIP01-0112
- BCIP01-0148
- BCIP01-0151
- BCIP01-0187
- BCIP01-0189
- BCIP01-0198
- BCIP01-0201
- BCIP01-0216
- BCIP01-0221
- BCIP01-0249
- BCIP01-0262
- BCIP01-0265
- BCIP01-0266
- BCIP01-0268
- BCIP01-0279
- BCIP01-0285
Distribution
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