Z-1333-2021 Class II Terminated
FDA device recall Z-1333-2021 was initiated by Biocare Medical, LLC on February 25, 2021 and is designated Class II. 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 instrume… The recall status is terminated (terminated January 31, 2023). Affected quantity: 72 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- February 25, 2021
- Termination Date
- January 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units
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.
Distribution Pattern
US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands
Code Information
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, BCIP01-0307, BCIP01-0314, BCIP01-0319, BCIP01-0328, BCIP01-0341, BCIP01-0346, BCIP01-0354, BCIP01-0386, BCIP01-0387, BCIP01-0388, BCIP01-0390, BCIP01-0395, BCIP01-0396, BCIP01-0413, BCIP01-0426, BCIP01-0430, BCIP01-0431, BCIP01-0432, BCIP01-0434, BCIP01-0443, BCIP01-0450, BCIP01-0463, BCIP01-0464, BCIP01-0467, BCIP01-0482, BCIP01-0484, BCIP01-0487, BCIP01-0491, BCIP01-0492, BCIP01-0495, BCIP01-0500, BCIP01-0502, BCIP01-0508, BCIP01-0517, BCIP01-0526, BCIP01-0534, BCIP01-0543, BCIP01-0545, BCIP01-0546, BCIP01-0550, BCIP01-0553, BCIP01-0555, BCIP01-0560, BCIP01-0562, BCIP01-0570, BCIP01-0571, BCIP01-0572, BCIP01-0573 Affected OUS serial numbers: BCIP01-0454, BCIP01-0515, BCIP01-0538, BCIP01-0556