Sysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard
Sysmex America is recalling 93 CF-70 instruments because a software mismatch may prevent the device from halting when the cover door is opened.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (failure to halt) that poses a risk of harm to operators, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sysmex America, Inc. is recalling 93 units of the CF-70 instrument (product code: LXG; Regulation Number: 862.2050). The CF-70 is a medical device that receives magazines containing stained blood smears from the SP-50, selects smears for analysis, and transports them to the DI-60. The recall is due to a software mismatch issue between the SP-50 and CF-70.
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, the operation of the CF-70 does not halt. This failure to stop the machine while the door is open presents a safety risk to operators.
The affected units were distributed nationwide in the United States, specifically in the states of AK, AR, AZ, CA, CO, CT, DE, FL, IL, KY, LA, MA, MD, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, TN, TZ, UT, and WA. The catalog number for the affected units is AH699752. Users should contact Sysmex America, Inc. for instructions on how to resolve the software mismatch and ensure the device halts correctly during maintenance or error conditions.
The recalled product
- Product
- 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
- Manufacturer
- Sysmex America, Inc.
- Affected units
- 93
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog No. AH699752.
Distribution
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