BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
This recall has been terminated (originally issued February 25, 2021).
- Company
- Biocare Medical, Llc
- Recall Initiated
- February 25, 2021
- Terminated
- January 31, 2023
- Recall Number
- Z-1333-2021
- Quantity
- 72 units
- Firm Location
- Pacheco, CA
- Official Source
- View on FDA website ↗
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
US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands
Lot / 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
Root Cause
Software Design Change
Action Taken
On 2/25/2021, BIOCARE Medical emailed and "Medical Device Recall" Notification to all affected consignees. In addition to informing consignees about the recall, the firm requested consignees take the following actions: 1. Do not use the product in the Multi Batching mode. 2. Do not interrupt a run during a Single Batch mode run or access the working deck while the instrument is in operation. 3. Always run positive controls per CAP and CLIA guidance to avoid the potential for false negative result from contaminated reagents. 4. If the malfunction does occur: " Do not open the cover and access the working deck. " Power cycle (turn off, then on) the device to reset it. " Look for spilled Wash Buffer solution on the lab bench and the floor. " Carefully examine the working deck and to determine if wash buffer has been spilled. If there is evidence of spilled wash buffer near, on or in reagent vials those vials should be disposed of to prevent staining performance issues. 5. PLEASE INDICATE YOUR UNDERSTANDING AND ACKNOWLEGEMENT OF THIS NOTICE BY COMPLETING THE STEPS LISTED BELOW 1. Locate all intelliPATH FLX Automated Staining Instruments in your possession. Verify the software version to confirm your device is impacted by this notice. 2. Ensure all personnel who may utilize the intelliPATH FLX are aware of this recall. 3. Complete and return the attached Response Form to Biocare Medical to acknowledge your receipt and understanding of this Recall Notice within 10 days of receipt. No return of product is necessary. This notification is being provided for awareness only. Biocare Medical continues to investigate this matter and will follow up with affected customers. Adverse events or quality problems experienced with the use of this product must be reported to Biocare Medical via techsupport@biocare.net.