Use cautionMedical device recall · FDA · Published February 25, 2021
Biocare IntelliPath FLX Staining Instrument Recall: Software Issue May Cause Unintended
Biocare Medical recalls IntelliPath FLX automated staining instruments with software version 3.5.3.1 due to potential unintended movement that could cause damage or liquid spills. Affected units include specific US and OUS serial numbers.
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.
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Contact the company
📍Recalling firmBiocare Medical, LLC60 Berry Dr · Pacheco, CA 94553-5601
✎ GovInfoNow plain-language explainer
Biocare Medical is recalling IntelliPath FLX automated staining instruments with software version 3.5.3.1. The software issue may cause the instrument to move unpredictably, potentially hitting end stops or causing wash buffer to spill on random locations. This could lead to equipment damage or liquid spills. Read more at govinfonow.com/recall/63230-biocare-intellipath-flx-staining-instrument-recall-software-issue-may-cause.
“Biocare IntelliPath FLX Staining Instrument Recall: Software Issue May Cause Unintended.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63230-biocare-intellipath-flx-staining-instrument-recall-software-issue-may-cause. Based on FDA recall #Z-1333-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1333-2021%22&limit=1).
The FDA announced on Feb. 25, 2021, that Biocare Medical, LLC voluntarily recalled its IntelliPath FLX Automated Staining Instrument due to potential software errors causing random movement and incorrect buffer dispensing. The agency issued recall number Z-1333-2021 for the Class II device.
Affected OUS Serial Numbers: BCIP01-0454, BCIP01-0515, BCIP01-0538, BCIP01-0556
Units Affected: 72
The hazard
According to the FDA, the automated staining instrument with software version 3.5.3.1 may move at random speeds and directions, potentially hitting end stops or other components on the working deck. This malfunction could also result in wash buffer being dispensed on random locations.
Context
GovInfoNow's records show Biocare Medical, LLC has had four other recalls since March 15, 2018. On Sept. 25, 2024, the company recalled an intelliPATH HRP Detection Kit due to potential test failures from weak staining. On Oct. 10, 2019, a 4plus Streptavidin HRP Label was recalled for risking invalid test results due to lack of staining. Other recent recalls of similar products include Fresenius Medical Care 5008X CAREsystem Recall (Oct. 25, 2025), Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (Dec. 23, 2025), and Fresenius Kabi Ivenix Infusion System Software Recall (Nov. 14, 2025).
How to tell if you have this one
Check for the model number IPS0001US or IPS0001INTL with software version 3.5.3.1. Affected units have specific US serial numbers listed in the recall notice and OUS serial numbers starting with BCIP01-0454.
Brand
Biocare Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your IntelliPath FLX instrument; if it is 3.5.3.1, it is affected.
Contact Biocare
Reach out to Biocare Medical for guidance on next steps and potential remedies.
Where it went and when
Where it was distributed
Distributed in 15 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1333-2021 (February 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1333-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.