Abbott Haptoglobin Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 5,694 Haptoglobin 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, but the source text indicates the issue is a documentation update (IFU) rather than a direct physical hazard or reported illness, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Abbott Laboratories, Inc. is recalling 5,694 kits of the Haptoglobin Assay (HP assay). This product is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The recall was initiated because an update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the Instructions for Use (IFU) was required due to different issues with the various products.
The affected kits were distributed nationwide, including Puerto Rico, and included government/military distribution. Foreign distribution was made to numerous countries, including Canada, Australia, China, India, and the United Kingdom. The recall applies to all Instructions for Use (IFU) associated with these kits.
Consumers and healthcare facilities should stop using the affected kits and contact Abbott Laboratories for further instructions regarding the updated documentation.
The recalled product
- Product
- The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming…
- Manufacturer
- Abbott Laboratories, Inc
- Hazard
- Affected units
- 5,694
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 C3 In Vitro Diagnostic Assay Recall for Instruction Manual Update
FDA (Devices) · 2019-07-31
Same hazard · documentation error
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- HighAbbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias
FDA (Devices) · 2020-04-15
- HighThyroglobulin Antibody Assay Instructions Incorrectly State Biotin Interference Resolution
FDA (Devices) · 2024-11-06
- ModerateAbbott Clinical Chemistry Phosphorus Reagent Recalled for Incorrect Expiration Dates
FDA (Devices) · 2013-10-23
- ModerateHyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert
FDA (Devices) · 2018-05-16
- HighAbbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results
FDA (Devices) · 2022-08-03
- HighAbbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results
FDA (Devices) · 2022-08-03