Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Reported: May 15, 2024 Initiated: April 5, 2024 #Z-1786-2024
Product Description
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Reason for Recall
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 40 units
- Distribution
- US Nationwide distribution.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115. Recalled by Randox Laboratories Ltd.. Units affected: 40 units.
Why was this product recalled? ▼
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2024. Severity: Low. Recall number: Z-1786-2024.
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