Sysmex recalls CF-70 blood analysis instruments with software mismatch between SP-50 and CF-70 models, which may cause analysis to continue without halting during error conditions.
Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.
Sysmex is recalling CF-70 blood analysis instruments that may continue running when an error occurs, potentially causing unsafe operation. This could affect labs using these instruments for blood smear analysis.
When the software versions between the SP-50 and CF-70 are mismatched, and an error condition requires opening the CF-70 cover door to remove slides or magazines, the instrument may not stop operation. This could lead to continued analysis of blood samples without proper safety checks.
Users of Sysmex CF-70 blood analysis instruments in medical laboratories are most at risk if they have software versions between SP-50 and CF-70 that don't match.
Check for Sysmex CF-70 instruments with product code LXG (Regulation Number 862.2050) that received magazines containing stained blood smears from SP-50 devices.
Verify that the software versions between SP-50 and CF-70 match to prevent unsafe operation during error conditions.
The recall is due to a software mismatch between SP-50 and CF-70 models that can cause the instrument to continue running when an error occurs, potentially leading to unsafe operation.
Check if your Sysmex CF-70 has matching software versions with SP-50 to prevent unsafe operation during error conditions.
The official recall does not specify a fix or remedy; users must check software versions to ensure compatibility.
We’ve drafted a message you can send Sysmex to request your refund or repair — edit it as you like.
Subject: Recall Z-1703-2020 — Sysmex Sysmex Hello, I own a Sysmex that is covered by recall Z-1703-2020 from Sysmex. 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.
