Drug recall
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use…
FDA recall event 94678 · Class II · SIGHT DIAGNOSTICS LTD
Key facts
| Event ID | 94678 |
|---|---|
| Recall numbers | Z-2173-2024 |
| Recalling firm | SIGHT DIAGNOSTICS LTD |
| Product type | Devices |
| Products | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot… |
| Initiation date | May 13, 2024 |
| Report date | Jul 3, 2024 |
| City | Tel Aviv-Yafo |
| Country | Israel |
| FEI number | 3016099075 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: