Biocare Medical, LLC Recall 87426
Description: BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Biocare Medical, LLC Recall 87426 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1333-2021 |
| Event ID | 87426 |
| Event Description | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 |
| Product Type | Devices |
| Distribution | US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands |
| Quantity | 72 units |
| Recall 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. |
| Device Classification | 20210407 |
| Device Code Info | 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 |
| Center Classification Date | 20210401 |
| Recall Initiation Date | 20210225 |
| Recalling Firm | Biocare Medical, LLC |
| Initial Notification | |
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