Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassa
FDA device recall Z-1399-2009 · posted 2009-05-26 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Reason for recall
- Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DGC
- Quantity affected
- 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
- Date initiated
- 2009-01-05
- Date posted
- 2009-05-26
- Date terminated
- 2010-04-19
- Location
- Flanders, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (K033234) | Diagnostic Products Corp. | 2003-12-12 |
| IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER (K970227) | Dpc Cirrus | 1997-04-08 |