Recall Z-1049-2009 ยท CGN Acid, Folic, Radioimmunoassay
Abbott Laboratories
AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20
| 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 | 1,142 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
| K972232 | ABBOTT AXSYM FOLATE Abbott Laboratories, Jun 24, 1997 |