Agency classClass IIOur severity:High FDA (Devices)·Z-1455-2022·Announced 2022-08-03

Abbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results

Abbott Laboratories is recalling the Alinity c Hemoglobin Reagent Kit because the ARCHITECT and Alinity c assays can generate falsely elevated Hemoglobin A1c results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall without reported illnesses, injuries, or hospitalizations. The hazard is a potential for falsely elevated test results, which presents a risk of incorrect clinical decisions. Per the rubric, this qualifies as a risk-of-harm scenario without reported injury, scoring at 3 (High).

Plain-English summary

Abbott Laboratories is recalling approximately 7,391 units of the Alinity c Hemoglobin Reagent Kit (REF: 08P4320). The affected product has been distributed throughout the United States and internationally to over 100 countries.

The ARCHITECT and Alinity c Hemoglobin A1c assays are capable of generating falsely elevated hemoglobin A1c test results when using affected reagent lots. Falsely elevated results may lead to incorrect clinical decisions regarding patient diagnosis and treatment.

The affected product is identified by UDI/DI 00380740135591 and the following lot numbers: 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, and 61658UQ01.

The recalled product

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
Manufacturer: Abbott Laboratories
Category: Medical Device — Diagnostic Reagent
Hazard: falsely-elevated-results
Affected units: 7,391

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

UDI/DI: 00380740135591/ Lots: 59561UQ04
59779UQ05
60229UQ07
60540UQ09
61011UQ10
61349UQ01
61658UQ01

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 3 recalled by Abbott Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Abbott Laboratories

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Same hazard · falsely elevated results