Alinity c Carbon Dioxide Reagent Kit — Class II medical device recall Z-0575-2020
Terminated recall by Abbott GmBH & Co. KG, reported 2019-12-04, distributed nationwide. Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity
| Recall number | Z-0575-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott GmBH & Co. KG, Wiesbaden, Germany |
| Recall initiated | 2019-10-23 |
| Classified | 2019-11-25 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, BE, BR, CA, CH, CO, DK, ES, FR, GB, GR, HK, IN, IT, JM, LB, NL, NZ, PH, PK, PL, PT, RO, SA, SE, SG, TH, TT, ZA |
| Lot numbers | 54449UQ03, 54454UQ03 |
| Model numbers | 07P7220, 07P7230 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0575-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.