Abbott Gmbh & Co. KG recalls Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

Recalled December 4, 2019 · FDA recall Z-0545-2020 · Abbott Gmbh & Co. KG

Hazard

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. · FDA Class II

Units

1,710 units

Sold at

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.

Description

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.

Product

Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

Manufacturer(s)

Abbott Gmbh & Co. KG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →