CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report
Alinity c Carbon Dioxide Reagent Kit, Produced recalled
Abbott GmBH & Co. KG is recalling Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I, distributed nationwide in the US. The recall was initiated on 23 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0575-2020
- FDA event ID
- 84140
- Recalling firm
- Abbott GmBH & Co. KG, Wiesbaden
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2019
- FDA classified
- 25 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Oct 2019 | Recall initiated by company | |
| 25 Nov 2019 | Classified by FDA | +33 days |
| 4 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Where it was distributed
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
Nationwide AlabamaArkansasCaliforniaColoradoFloridaGeorgiaIdahoIllinoisLouisianaMassachusettsMichiganMinnesotaMissouriNorth CarolinaNew YorkOklahomaPennsylvaniaPuerto RicoSouth CarolinaSouth Dakota
Questions about this recall
Why was it 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.
Which lots are affected?
REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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