Recall Z-1047-2009 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Abbott Laboratories
AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20
| Date | Apr 15, 2009 (initiated Jan 19, 2009) |
| Status | Terminated |
| Reason | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| Root cause | Employee error |
| Action | Consignees were sent a Product Correction-Immediate Action Required letter on 1/19/09. The letter informed users of the reported increased frequency of probe crashes when using the affected reagent pack lots and provided instructions on what actions the laboratory can take if they have a defective reagent pack or experience a probe crash with their system. Users need to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading reagent pack on instrument; and disc |
| Quantity | 3,338 kits |
| Distribution | Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953943 | AXSYM CMV IGG ANTIBODY ASSAY Abbott Laboratories, Sep 20, 1996 |