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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Fluidics PCB

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 Class 2 Device Recall Digital Fluidics PCBsee related information
Date Initiated by FirmJanuary 05, 2009
Date PostedMay 26, 2009
Recall Status1 Terminated 3 on April 19, 2010
Recall NumberZ-1399-2009
Recall Event ID 50849
510(K)NumberK033234 K970227 
Product Classification Ige, antigen, antiserum, control - Product Code DGC
ProductImmulite 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 IMMULITE 2000: Serial Numbers M5080 to M5137; and IMMULITE 2500: Serial Numbers F0778 to F0818.
FEI Number 1000122204
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
62 Flanders-Bartley Rd
Flanders NJ 07836-4715
For Additional Information ContactDavid Stein
914-524-2299
Manufacturer Reason
for Recall		Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.
FDA Determined
Cause 2		Process design
ActionSiemens 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 Commerce295 Digital Fludics PCB (88 IMMULITE 2000 and 2500 and 207 as spare parts).
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DGC
510(K)s with Product Code = DGC
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