Home / Recalls / Sentinel CH SpA / Z-2552-2019

Z-2552-2019 Class II Terminated

Recalled by Sentinel CH SpA — Milan

FDA device recall Z-2552-2019 was initiated by Sentinel CH SpA on June 28, 2019 and is designated Class II. Reason for recall: Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehy… The recall status is terminated (terminated July 24, 2020). Affected quantity: 1217 kits.

Recall Details

Product Type
Devices
Report Date
October 2, 2019
Initiation Date
June 28, 2019
Termination Date
July 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1217 kits

Product Description

Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

Reason for Recall

Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

Distribution Pattern

Nationwide Foreign: ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BANGLADESH BELARUS BELGIUM BOSNIA AND HERZEGOVI BRAZIL BRUNEI CANADA CHILE COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK FAROE ISLANDS FINLAND FRANCE GERMANY GREECE GREENLAND HONG KONG IRELAND ISRAEL ITALY JORDAN KUWAIT LEBANON LUXEMBOURG MALAYSIA MALDIVES MEXICO MOROCCO NETHERLANDS NEW ZEALAND NIGERIA NORWAY OMAN PAKISTAN PANAMA PARAGUAY PHILIPPINES POLAND PORTUGAL PUERTO RICO ROMANIA RWANDA SAUDI ARABIA SLOVAKIA SOUTH AFRICA SPAIN ST. VINCENT SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UAE UNITED KINGDOM URUGUAY

Code Information

Lot Number/UDI: 80553Y600/ (01)00380740136277 (17)190731(10)80553Y600; 80444Y600/ (01)00380740136277 (17)190731(10)80444Y600; 80625Y600/ (01)00380740136277 (17)191130(10)80625Y600; 90224Y600/ (01)0038074013627 (17)200229(10)90224Y600

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-2867-2017 Class II — MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Int (May 22, 2017)
  • Z-0164-2016 Class II — Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measur (September 22, 2015)

FDA data resources