Z-1703-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- March 9, 2020
- Termination Date
- March 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93 units.
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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..
Code Information
Catalog No. AH699752.