Beckman Coulter recalls UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) due to potential cell carryover causing erroneous lab results. Affected units have specific serial numbers and catalog numbers.
When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.
Beckman Coulter is recalling two blood analysis devices that may cause inaccurate lab results if the dispense probe is slightly bent. This could lead to unnecessary or inappropriate patient treatments. The recall affects specific models with listed serial numbers.
If the dispense probe is slightly bent, blood samples from previous tests may carry over to the next sample. This can cause the lab to report incorrect results, potentially leading to unnecessary or inappropriate patient treatments.
Lab technicians and healthcare facilities using the UniCel DxH Slidemaker Stainer or UniCel DxH Slidemaker Stainer II devices. Patients at risk if the device produces inaccurate lab results.
Check if your device has the serial numbers listed in the recall (e.g., AS39017, AT35013, etc.) or catalog numbers B66705 and C11477. The devices are used for blood sample preparation in labs.
Compare your device's serial number with the list of affected serial numbers provided in the recall.
The UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II may have a slightly bent dispense probe, which can cause cell carryover from previous samples and lead to erroneous lab results.
Check your device's serial number against the list of affected serial numbers provided in the recall. If it matches, contact Beckman Coulter for further instructions.
The recall states that erroneous results may lead to unnecessary or inappropriate patient treatments, but there is no mention of direct injury or serious harm from the device itself.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0516-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0516-2020 from Beckman Coulter. 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.
