The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1988-2019·Announced 2019-07-31

Abbott Immunoglobulin A Diagnostic Assay Recalled for Instruction Manual Errors

Abbott Laboratories is recalling 12,995 Immunoglobulin A diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is a required update to the Instructions for Use (documentation) and does not report any illnesses or injuries. Per the rubric, minor labeling/documentation errors without reported harm fall under Moderate.

Plain-English summary

Abbott Laboratories, Inc. is recalling 12,995 kits of the Immunoglobulin A in vitro diagnostic assay. This product is used for the quantitative determination of immunoglobulin A in human serum or plasma. The recall was initiated because an update to the Instructions for Use (IFU) was required to address different issues with the various products.

The specific issues necessitating the recall involved the 'Reagents' and 'Specimen Collection and Handling/Preparation for Analysis' sections of the IFU. The source text does not specify the exact nature of the errors or the potential impact on test results, only that the documentation required updating.

Distribution was nationwide, including Puerto Rico, and included government/military distribution. The product was also distributed to numerous foreign countries. The source text does not report any illnesses, injuries, or adverse health consequences associated with this recall.

The recalled product

Product
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light…
Manufacturer
Abbott Laboratories, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
12,995

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 (1)

  • All IFU's

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Abbott Laboratories, Inc 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 9 products in this recall →

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