Recall Z-1455-2022— Abbott Laboratories

Name: FDA recall Z-1455-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-09

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, initiated 2022-06-09. It names one FDA 510(k) clearance: K130255. Product: REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL. Reason: 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..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2022-06-09
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K130255 — HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLSAbbott Laboratories·cleared 2014-02-28

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

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Reason for recall

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.

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