Recall Z-1033-2010 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Siemens Healthcare Diagnostics Inc.
IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
| Date | Mar 10, 2010 (initiated Oct 21, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units) due to incompatibility of the Toxoplasma IgM kits with this particular lot of IgG/IgM Sample Diluent. All available lots of the IMMULITE 2000/2500 Toxoplasma IgM kits (L2KTM/L5KTM) are incompatible with Diluent lot 150 |
| Root cause | Nonconforming Material/Component |
| Action | The customer notification was initiated on 10/22/2009 with the firm forwarding an Urgent Field Safety notice with attached Field Correction Effectiveness Check form to the affected consignees informing them of the issue and the products affected. The consignees were informed that Siemens is initiating the Field Correction (FC) to prevent IMMULITE 2000/2500 Toxoplasma IgM from being run with Diluent lot 150. The consignees were instructed in the interim, until replacement kit lots of RUB IgG and CMV IgG are received, your laboratory can continue using Rubella IgG, CMV IgG, or Toxoplasma IgM as |
| Quantity | 557 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |