Recall Z-1993-2019— Abbott Laboratories, Inc
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2018-05-16, terminated 2021-08-16. FDA's recall record names no specific 510(k) clearance for this event. 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 immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.. Reason: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products..
- Recalling firm
- Abbott Laboratories, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-16
- Terminated
- 2021-08-16
- Firm location
- Irving, TX, United States
Product description
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 immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.
Reason for recall
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Data sourced from openFDA. This site is unofficial and independent of the FDA.