FDA Device recall Z-1993-2019
The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay by Abbott Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1993-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-16 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
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.
Identifiers
| code_info | All IFU's |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2019%22
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