Z-0575-2020 Class II Terminated
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