Recall Z-0575-2020— Abbott GmBH & Co. KG

Name: FDA recall Z-0575-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-23

Class II · Terminated

Class II FDA medical device recall by Abbott GmBH & Co. KG, initiated 2019-10-23, terminated 2021-05-14. It names one FDA 510(k) clearance: K060295. Product: Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada. 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..

Recalling firm: Abbott GmBH & Co. KG
Classification: Class II
Status: Terminated
Initiated: 2019-10-23
Terminated: 2021-05-14
Firm location: Wiesbaden, Germany

510(k) clearances named in this recall

1 on FDA's record

K060295 — CARBON DIOXIDEAbbott Laboratories·cleared 2006-05-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.