Alinity c Carbon Dioxide Reagent Kit recall
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Why was Alinity c Carbon Dioxide Reagent Kit recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03
- Product
- Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
- Recalling firm
- Abbott GmBH & Co. KG
- Quantity
- 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)
- Distribution
- 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
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)