FDA Medical Device Recalls (openFDA)
Biocare Medical, LLC: BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
- Recall number
- Z-1333-2021
- Recalling firm
- Biocare Medical, LLC
- Product
- BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
- Status
- Terminated
- Initiated
- 2021-02-25
- Posted
- not on file
- Terminated
- 2023-01-31
- 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.
- Root cause
- 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
- 72 units
- Distribution
- US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPA
- Firm FEI
- 3004140393
- Firm city
- Pacheco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28