Reported Dec 4, 2019 · Terminated
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Abbott GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott GmBH & Co. KG · Max-Planck-Ring 2 · Wiesbaden · N/A
Is this the product you have?
- Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
- Lot codes and dates
- REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03
- Amount recalled
- 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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