Home / Recalls / Abbott Gmbh & Co. KG / Z-0543-2020

Z-0543-2020 Class II Ongoing

Recalled by Abbott Gmbh & Co. KG — Wiesbaden

Recall Details

Product Type
Devices
Report Date
December 4, 2019
Initiation Date
September 16, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,714 units

Product Description

Alinity ci Level Sensor, Bulk Solution

Reason for Recall

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

Distribution Pattern

Nationwide distribution to AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OK, PR, SC, SD, TN, TX, UT, VA, WA, WI. International distribution to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, 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, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, VIETNAM.

Code Information

List Number 04S68-02, All Serial Numbers

Other recalls by Abbott Gmbh & Co. KG

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