Abbott Laboratories 2022-08-03 Health serious FDA
Health · FDA · Recall #FDA-Z-1456-2022
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3… Recall
Issued August 3, 2022 · Abbott Laboratories
In August 2022, Abbott Laboratories recalled the REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
What you should do
- 1 Stop using REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abbott Laboratories to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Abbott Laboratories
- Category
- Health
- Recall date
- August 3, 2022
- Units affected
- Not reported
- Sold at
- US: AK AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NJ NV NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: A
- Recall number
- FDA-Z-1456-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Abbott Laboratories has 31 recalls in our database, including 19 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.