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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliPath FLX, Automated Staining Instrument

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  Class 2 Device Recall IntelliPath FLX, Automated Staining Instrument see related information
Date Initiated by Firm February 25, 2021
Create Date April 01, 2021
Recall Status1 Terminated 3 on January 31, 2023
Recall Number Z-1333-2021
Recall Event ID 87426
Product Classification Slide stainer, automated - Product Code KPA
Product BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
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
Recalling Firm/
Manufacturer		 Biocare Medical, LLC
60 Berry Dr
Pacheco CA 94553-5601
For Additional Information Contact Theodore Morris
925-603-8002
Manufacturer 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.
FDA Determined
Cause 2		 Software Design Change
Action 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.
Quantity in Commerce 72 units
Distribution US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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