Home / Recalls / Abbott GmBH & Co. KG / Z-0575-2020

Z-0575-2020 Class II Terminated

Recalled by Abbott GmBH & Co. KG — Wiesbaden

FDA device recall Z-0575-2020 was initiated by Abbott GmBH & Co. KG on October 23, 2019 and is designated Class II. Reason for recall: Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was ma… The recall status is terminated (terminated May 14, 2021). Affected quantity: 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03).

Recall Details

Product Type: Devices
Report Date: December 4, 2019
Initiation Date: October 23, 2019
Termination Date: May 14, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)

Product Description

Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada

Reason for Recall

Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.

Distribution Pattern

Worldwide and US Nationwide in the states of: AL, AR, CA, CO, FL, GA, ID, IL, LA, MA, MI, MN, MO, NC, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico Foreign: AUSTRALIA, BANGLADESH, BELGIUM, BOTSWANA, BRAZIL, CANADA, COLOMBIA, DENMARK, FRANCE, GREECE, Hong Kong, INDIA, ITALY, JAMAICA, LEBANON, MAURITIUS, NAMIBIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UAE, and UNITED KINGDOM

Code Information

REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03

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