Recall Z-0575-2020 ยท KHS Enzymatic, Carbon-Dioxide
Abbott GmBH & Co. KG
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
| Date | Oct 23, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On 10/23/19, a Product Recall letter was issued to all worldwide Alinity c Carbon Dioxide Reagent customers who received the in-date lots. US customers were sent this information via FedEx priority overnight. Customers are asked to immediately discontinue use and destroy product from LN 07P7230 lot 54449UQ03. For LN 07P7220 lot 54454UQ03, the product may continue to be used but 2 levels of CO2 controls must be run every hour until the new material is received. If you or any of the health care providers you serve have any questions regarding this information, US Customers can contact Custom |
| 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, JAMA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060295 | CARBON DIOXIDE Abbott Laboratories, May 4, 2006 |