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.
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.
The software version 3.5.3.1 may cause the instrument to move randomly in unpredictable directions and speeds. This could result in the instrument hitting end stops, colliding with other components on the working deck, or dispensing wash buffer in unintended locations.
Users of the IntelliPath FLX instrument with specific US and OUS serial numbers are affected. Laboratory technicians and medical staff who operate this equipment are most at risk.
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.
Verify the software version on your IntelliPath FLX instrument; if it is 3.5.3.1, it is affected.
Reach out to Biocare Medical for guidance on next steps and potential remedies.
Software version 3.5.3.1 is affected.
Affected US serial numbers include BCIP01-0021, BCIP01-0033, and others listed in the recall notice. OUS serial numbers starting with BCIP01-0454 are also affected.
Check for model number IPS0001US or IPS0001INTL with software version 3.5.3.1. Affected units have specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Biocare Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1333-2021 — Biocare Medical Biocare Medical Hello, I own a Biocare Medical that is covered by recall Z-1333-2021 from Biocare Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
