BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1

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.

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

Distribution pattern: US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands