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U.S. Department of Health and Human Services

Class 2 Device Recall Sysmex CF70

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  Class 2 Device Recall Sysmex CF70 see related information
Date Initiated by Firm March 09, 2020
Create Date April 14, 2020
Recall Status1 Terminated 3 on March 24, 2021
Recall Number Z-1703-2020
Recall Event ID 85254
Product Classification Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
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 are placed back in magazines.
Code Information Catalog No. AH699752.
Recalling Firm/
Manufacturer		 Sysmex America, Inc.
577 Aptakisic Rd
Lincolnshire IL 60069-4325
For Additional Information Contact Nancy Gould
815-403-8515
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Sysmex America, Inc. notified customers on 03/09/2020 via "Product Notification SP-50 and CF-70 Software Mismatch Field Correction" letter. The recall letter identified the affected product and model numbers. The customers were asked to verify the software version. If the versions did not match, a service visit is required for the correction of the software mismatch.
Quantity in Commerce 93 units.
Distribution 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..
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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