Immulite 2000 and Immulite 2500 digital Fluidics PC Board recallZ-1399-2009 · Siemens Medical Solutions Diagnostics · initiated Jan 5, 2009
Terminated All recalls posted in May 2009
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 Medical Solutions Diagnostics 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
Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.
FDA root cause category: Process design
What the company is doing
Siemens Healthcare Diagnostics Inc. issued an "Urgent: Device Recall" notice dated January 2009 mailed to all direct customers of the affected product. The letter described the problem, provided "work-around" instructions and also provided a Recall Response Form to be returned to the firm via fax. For further information, please contact your local Siemens Healthcare support representative or Siemens Healthcare Diagnostics Inc. directly at 1-973-927-2828.
Recall details
- Recall number
- Z-1399-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 5, 2009
- Posted by the FDA
- May 26, 2009
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Quantity
- 295 Digital Fludics PCB (88 IMMULITE 2000 and 2500 and 207 as spare parts).
- Product code
- DGC
- FDA submissions
- K033234, K970227
- Distribution
- Worldwide Distribution to states including MA, NY, PA, MD, GA, FL, OH, IN, MI, IL, MO, LA, UT, AZ and CA and countries of Canada, Czech Republic, Germany, Poland, Hungary, Belgium, Russia, Republic of South Africa, Greece, Israel, Turkey, Spain, Portugal, Denmark, France, Great Britain, India, China, South Korea and Mexico.
Product description
Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.
Code information (models, lots, serial numbers)
IMMULITE 2000: Serial Numbers M5080 to M5137; and IMMULITE 2500: Serial Numbers F0778 to F0818.
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.
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