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Recall Observatory FDA recall evidence

Device product

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

Z-0544-2020

September 16, 2019

Class II

Product summary

Firm
Abbott Gmbh & Co. KG
Event
Event 83847
Status
Ongoing
Classification
Class II
Quantity
3,271 units
Official record key
device-enforcement:Z-0544-2020

Official wording

Reason: 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.

Code information: List Number 03R66 03, All Serial Numbers

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.