Recall Z-1987-2019 ยท CZW Complement C3, Antigen, Antiserum, Control
Abbott Laboratories, Inc
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 increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 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 | 8,132 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
| K983441 | C3 Abbott Laboratories, Nov 4, 1998 |