IMMULITE 2000 and IMMULITE 2500 recallZ-1033-2010 · Siemens Healthcare Diagnostics Inc. · initiated Oct 21, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1033-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 21, 2009
- Posted by the FDA
- Mar 10, 2010
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Quantity
- 557 units
- Product code
- LFX
- FDA submissions
- K033234, K970227
- Distribution
- Nationwide
Product description
IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
Code information (models, lots, serial numbers)
Lot Number 150
Other devices under the same FDA submission
3 devices cleared under K033234, K970227 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMULITE® 2000 XPi Immunoassay System 10373214Siemens Healthcare Diagnostics Products Ltd · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE286 reports
- VersaCell® X3 10793839Siemens Healthcare Diagnostics Products Ltd · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE3 reports
- IMMULITE® 2000 Systems TSH Third Generation TSH 10381665Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page