Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The CF-70 instrument (product code: LXG Recalled by Sysmex America, Inc. Due to Software mismatch-When the software versions between the SP-50...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sysmex America, Inc. directly.
Affected Products
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
Quantity: 93 units.
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sysmex America, Inc.
Sysmex America, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report