Cellavision AB recalls software versions 6.0.1 and 6.0.2 for DM96, DM1200, and DM9600 devices. These versions may not send WBC, RBC, and PLT data to lab systems when processing multiple slides per blood sample.
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
Cellavision AB is recalling software versions 6.0.1 and 6.0.2 for specific blood cell analysis devices. This issue means that when multiple slides are processed per blood sample, critical blood cell data may not be sent to the lab system, potentially causing incomplete test results.
The software malfunction prevents WBC, RBC, and PLT (white blood cells, red blood cells, and platelets) data from being sent to the lab information system when multiple slides are processed per blood sample. This can lead to incomplete test results if the lab system doesn't receive the data.
Skilled laboratory technicians using Cellavision DM96, DM1200, or DM9600 devices with software versions 6.0.1 or 6.0.2. Those processing multiple blood slides per sample are most at risk of incomplete test results.
Check if your Cellavision DM96, DM1200, or DM9600 device has software versions 6.0.1 or 6.0.2 installed. The devices are used for automated blood cell analysis in labs.
Review your Cellavision device's software version to confirm if it is 6.0.1 or 6.0.2.
The software versions 6.0.1 and 6.0.2 have a malfunction that prevents WBC, RBC, and PLT data from being sent to the lab system when multiple slides are processed per blood sample.
The recall record does not specify a remedy, so no action is required beyond checking your software version.
The recall record does not mention any safety hazards that could cause injury; the issue is limited to incomplete test results.
We’ve drafted a message you can send Cellavision to request your refund or repair — edit it as you like.
Subject: Recall Z-2184-2018 — Cellavision Cellavision Hello, I own a Cellavision that is covered by recall Z-2184-2018 from Cellavision. 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.
