Recall Z-1989-2019 ยท DEW Igg, Antigen, Antiserum, Control
Abbott Laboratories, Inc
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.
| Date | May 16, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| 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, Bru |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983221 | IGG Abbott Laboratories, Nov 4, 1998 |