Recall Z-1994-2019— Abbott Laboratories, Inc

Name: FDA recall Z-1994-2019
Creator: U.S. Food and Drug Administration
Published: 2018-05-16

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2018-05-16, terminated 2021-08-16. It names one FDA 510(k) clearance: K983281. Product: Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.. 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

510(k) clearances named in this recall

1 on FDA's record

K983281 — APOBAbbott Laboratories·cleared 1999-01-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.

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.