Recall Z-1685-2011 ยท CGF Radioimmunoassay, Estrone
Beckman Coulter Inc.
Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.
| Date | Mar 17, 2011 (initiated Apr 22, 2010) |
| Status | Terminated |
| Reason | Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired and should not be in active use any more. |
| Root cause | Other |
| Action | Beckman Coulter released an Urgent: Product Corrective Action letter dated July 9, 2010 identifying the affected product and informing consignees of the reason for recall, asking them to take the following actions: *For lots 992637, 100115A, 100205A, 100205RA, and 100226A, review historical external quality control results relevant to the patients' results obtained with these lots to ensure the assay performance was within laboratory specifications. *For lots 100319A, 100409A, 100409RA, review patents' results obtained with the results of external quality control and interpret them in the lig |
| Quantity | 917 units |
| Distribution | Worldwide Distribution -- US, including states of CA, FL, GA, IL, IN, KS, MI, NC, NY, OH, OR, TX, VA, WA, and WI and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935013 | DSL ESTRONE (DSL 8700) Diagnostic Systems Laboratories, Inc., Jun 16, 1994 |