Reported Apr 22, 2020 · Terminated
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood…
Sysmex America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sysmex America, Inc. · 577 Aptakisic Rd · Lincolnshire, IL · 60069-4325
Is this the product you have?
- The CF-70 instrument (product codeLXG
- Regulation Number862.2050) 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
- Lot codes and dates
- Catalog No. AH699752.
- Amount recalled
- 93 units.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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