FDAFDA · Food and drugs·Recall number Z-1703-2020
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.
Published April 22, 2020 · Recall initiated: March 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sysmex America, Inc.
- Distributor
- USA nationwide distribution 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..
- Lot
- Catalog No. AH699752.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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