Home / Recalls / Abbott Gmbh & Co. KG / Z-2701-2020

Z-2701-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
August 5, 2020
Initiation Date
June 19, 2020
Termination Date
April 10, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3166

Product Description

Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below

Reason for Recall

Quality Control results were not properly evaluated for QC failures.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MADAGASCAR, MALAYSIA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, UKRAINE, URUGUAY, VIETNAM.

Code Information

All serial numbers of System Control Module

Other recalls by Abbott Gmbh & Co. KG

  • 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-0543-2020 Class II — 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-2363-2019 Class II — Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: (June 10, 2019)