Z-1399-2009

Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent...

Name: Z-1399-2009 Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent...
Creator: Siemens Medical Solutions Diagnostics
Published: 2009-01-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-01-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions Diagnostics began a recall of Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine... on 2009-01-05. The reason FDA records is "Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1399-2009
Status: Terminated
Initiated: 2009-01-05
Posted: 2009-05-26
Terminated: 2010-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: DGC Ige, Antigen, Antiserum, Control
Reason for recall: Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 295 Digital Fludics PCB (88 IMMULITE 2000 and 2500 and 207 as spare parts).
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 codes and lots: IMMULITE 2000: Serial Numbers M5080 to M5137; and IMMULITE 2500: Serial Numbers F0778 to F0818.

Product code DGC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)