[Recalled] 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
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Sysmex America, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1703-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 March 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Sysmex America, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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