—#89379

Product

IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150

FDA product code: LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot Number 150

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 long as Diluent Lot 150 is not loaded on the analyzer when running Toxoplasma IgM. Diluent Lot 150 can be used with RUB IgG and CMV IgG. Once the replacements lots are received, any unopened kit lots listed in the above table MUST BE RETURNED to Siemens per instructions that will accompany a separate Fed Ex Call Tag that will explain the proper return of the affected product. The consignees were also instructed to complete the attached Field Correction Effectiveness Check form and fax to the firm's technical solutions center. Additional questions should be directed to the firm at 973-927-2828.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc.
Address: 5700 W 96th St, Los Angeles, California 90045-5544

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2009-10-21
Posted by FDA: 2010-03-10
Terminated: 2010-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89379. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.