Abbott Apolipoprotein A1 Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 2,112 Apolipoprotein A1 assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
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, and the source text identifies the issue as a required update to the Instructions for Use (IFU) rather than a reported injury or contamination event, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Abbott Laboratories, Inc. is recalling 2,112 kits of the Apolipoprotein A1 in vitro diagnostic assay. This product is used for the quantitative determination of apolipoprotein A1 in human serum or plasma. The recall covers all Instructions for Use (IFU) associated with the product.
The recall was initiated because an update to the 'Reagents' and 'Specimen Collection and Handling/Preparation for Analysis' sections of the IFU was required. The source text indicates that these updates were necessary due to different issues with the various products.
Distribution was nationwide, including Puerto Rico, and included government/military distribution. The product was also distributed to numerous foreign countries. Users should refer to the updated Instructions for Use for the correct reagent and specimen handling procedures.
The recalled product
- Product
- Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an…
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 2,112
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
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 →Related recalls
Same manufacturer · Abbott Laboratories, Inc
See all →- HighAbbott Alinity s System software error affects diagnostic analyzer wash cycle
FDA (Devices) · 2022-03-23
- HighAutomated diagnostic analyzer from Abbott recalled for waste pressure buildup
FDA (Devices) · 2021-08-18
- HighAbbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk
FDA (Devices) · 2020-04-15
- ModerateAbbott APS Accelerator Modules Recalled for Missing Pacemaker Safety Label
FDA (Devices) · 2019-10-02
- ModerateAbbott Immunoglobulin G Diagnostic Assay Recall for IFU Updates
FDA (Devices) · 2019-07-31
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateAbbott Clinical Chemistry Phosphorus Reagent Recalled for Incorrect Expiration Dates
FDA (Devices) · 2013-10-23
- HighAbbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results
FDA (Devices) · 2022-08-03
- HighAbbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias
FDA (Devices) · 2020-04-15
- HighAbbott Alinity i Estradiol Reagent Kit Recalled for False Results
FDA (Devices) · 2019-05-22
- HighAutomated diagnostic analyzer from Abbott recalled for waste pressure buildup
FDA (Devices) · 2021-08-18
- ModerateAbbott Recalls Alinity i Ferritin Reagent Kits Due to Manufacturing Defect
FDA (Devices) · 2019-08-14