Home / Recalls / Sentinel CH SpA / Z-0164-2016

Z-0164-2016 Class II Terminated

Recalled by Sentinel CH SpA — Milano, N/A

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.

Other recalls by Sentinel CH SpA

  • Z-0325-2024 Class II — IRON assay, Reference Numbers 6K95-41 and 6K95-30 (September 29, 2023)
  • Z-0326-2024 Class II — Alinity c Iron Reagent, Reference Number 08P3920 (September 29, 2023)
  • Z-0033-2022 Class III — Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Prod (July 29, 2021)
  • Z-2012-2021 Class III — ACE Control Set - IVD Control set for the quantitative determination of Angioten (April 30, 2021)
  • Z-2551-2019 Class II — MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma u (June 28, 2019)
  • Z-2552-2019 Class II — Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum (June 28, 2019)
  • Z-2867-2017 Class II — MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Int (May 22, 2017)