Z-0164-2016 Class II Terminated
FDA device recall Z-0164-2016 was initiated by Sentinel CH SpA on September 22, 2015 and is designated Class II. 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. The recall status is terminated (terminated March 30, 2016). Affected quantity: 765 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2015
- Initiation Date
- September 22, 2015
- Termination Date
- March 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 765 kits
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Lot 50083Y600, expiration date 31 Jul 2016.