FDA (Devices) recall action 83189

Abbott Laboratories, Inc recalled 9 products on 2019-07-31

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2019-07-31
Critical: 0
Units: 82,251

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

ModerateFDA (Devices)··2019-07-31
Abbott Immunoglobulin A Diagnostic Assay Recalled for Instruction Manual Errors
Abbott Laboratories is recalling 12,995 Immunoglobulin A diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.
Product
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scat
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
Abbott Apolipoprotein B Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 2,273 Apolipoprotein B in vitro diagnostic kits because the Instructions for Use (IFU) required updates to reagent and specimen handling sections.
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 increa
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
Abbott Transferrin Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 22,359 Transferrin in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
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.
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 i
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
Abbott Immunoglobulin M Diagnostic Assay Recalled for Instruction Manual Errors
Abbott Laboratories is recalling 9,586 Immunoglobulin M diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.
Product
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scat
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
Abbott Immunoglobulin G Diagnostic Assay Recall for IFU Updates
Abbott Laboratories is recalling 11,063 Immunoglobulin G in vitro diagnostic kits to update instructions for use regarding reagents and specimen handling.
Product
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scat
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
Abbott C3 In Vitro Diagnostic Assay Recall for Instruction Manual Update
Abbott Laboratories is recalling 8,132 C3 in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increa
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
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.
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 incr
Category
Distribution
1 state
ModerateFDA (Devices)··2019-07-31
Abbott C4 In Vitro Diagnostic Assay Recall for Instruction Manual Updates
Abbott Laboratories is recalling 8,037 C4 in vitro diagnostic assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading t
Category
Distribution
1 state