Recall Z-1989-2019
Abbott Laboratories, Inc · initiated May 16, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.
Codes / lots: All IFU's
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.
FDA-determined cause: Under Investigation by firm
Action taken
The recalling firm issued letters dated 5/16/2019 via FedEx priority overnight express on 5/16/2019 to the U.S. customers. For OUS, each country organization needs to establish their own method of notification, which normally consists of mailings or customer visits.
Details
- Recall number
- Z-1989-2019
- Initiated
- May 16, 2018
- Terminated
- August 16, 2021
- Product code
- DEW – Igg, Antigen, Antiserum, Control
- Quantity
- 11,063 kits
- Distribution
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech…
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1987-2019 Class II | C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1988-2019 Class II | Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1990-2019 Class II | Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1991-2019 Class II | Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1992-2019 Class II | C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1993-2019 Class II | The,K -ASSAY HP assay is intended for the quantitative determination of human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1994-2019 Class II | Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1995-2019 Class II | Transferrin is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |