Recall Z-1399-2009 ยท DGC Ige, Antigen, Antiserum, Control
Siemens Medical Solutions Diagnostics
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.
| Date | May 26, 2009 (initiated Jan 5, 2009) |
| Status | Terminated |
| Reason | Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper. |
| 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 | 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 |
| FDA record | Open on fda.gov |