Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Reported: November 4, 2015 Initiated: September 22, 2015 #Z-0164-2016
Product Description
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Reason for Recall
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Details
- Recalling Firm
- Sentinel CH SpA
- Units Affected
- 765 kits
- Distribution
- Nationwide Distribution.
- Location
- Milano, N/A
Frequently Asked Questions
What product was recalled? ▼
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.. Recalled by Sentinel CH SpA. Units affected: 765 kits.
Why was this product recalled? ▼
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0164-2016.
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