Z-1333-2021Class II

BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and...

Name: Z-1333-2021 BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and...
Creator: Biocare Medical, LLC
Published: 2021-02-25
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2021-02-25 / Terminated / root cause: software

FDA source

Biocare Medical, LLC began a recall of BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 on 2021-02-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1333-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-25
Posted: 2021-04-01
Terminated: 2023-01-31
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
Product code: KPA Slide Stainer, Automated
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.
Root cause tag: software
FDA 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 [email protected].
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1333-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1333-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-04-01

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)