Home / Recalls / Abbott Gmbh & Co. KG / Z-1497-2019

Z-1497-2019 Class II Terminated

Recalled by Abbott Gmbh & Co. KG — Wiesbaden, N/A

FDA device recall Z-1497-2019 was initiated by Abbott Gmbh & Co. KG on April 5, 2019 and is designated Class II. Reason for recall: Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test … The recall status is terminated (terminated September 28, 2022). Affected quantity: 373 units total.

Recall Details

Product Type
Devices
Report Date
June 5, 2019
Initiation Date
April 5, 2019
Termination Date
September 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
373 units total

Product Description

Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

Reason for Recall

Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.

Distribution Pattern

Worldwide Distribution - US Nationwide to Oklahoma and Texas. Distributed worldwide to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, MADAGASCAR, MEXICO, NETHERLANDS, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM, VIETNAM.

Code Information

Part Number: 03R65 01, all Serial Numbers; a. TED (Thermo Electric Device) Engine, Reagent cooler - Part Numbers A 30103732 01, A 30103732 02 with all Serial Numbers; b. CABLE, POWER OUT, TED CNTRLER - Part Numbers A 35006203 01, A 35006203 02 with all Serial Numbers

Other recalls by Abbott Gmbh & Co. KG

  • Z-2701-2020 Class II — Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series sof (June 19, 2020)
  • Z-2401-2020 Class II — Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. (May 12, 2020)
  • Z-2117-2020 Class II — ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are (April 24, 2020)
  • Z-1728-2020 Class II — ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. (March 9, 2020)
  • Z-1580-2020 Class II — LN 3R70-01; software version 2.6.2 and earlier. The software is used with the A (January 24, 2020)
  • Z-0574-2020 Class II — ARCHITECT HAVAB-G Calibrator, REF 6L27-01 (November 7, 2019)
  • Z-0575-2020 Class II — Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostic (October 23, 2019)
  • Z-0544-2020 Class II — Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution (September 16, 2019)
  • Z-0545-2020 Class II — Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution (September 16, 2019)
  • Z-0543-2020 Class II — Alinity ci Level Sensor, Bulk Solution (September 16, 2019)

FDA data resources