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Class 2 Device Recall Digital Fluidics PCB |
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Date Initiated by Firm |
January 05, 2009 |
Date Posted |
May 26, 2009 |
Recall Status1 |
Terminated 3 on April 19, 2010 |
Recall Number |
Z-1399-2009 |
Recall Event ID |
50849 |
510(K)Number |
K970227 K033234
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Product Classification |
Ige, antigen, antiserum, control - Product Code DGC
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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.
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Code Information |
IMMULITE 2000: Serial Numbers M5080 to M5137; and IMMULITE 2500: Serial Numbers F0778 to F0818. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions Diagnostics 62 Flanders-Bartley Rd Flanders NJ 07836-4715
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For Additional Information Contact |
David Stein 914-524-2299
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Manufacturer Reason for Recall |
Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DGC and Original Applicant = DIAGNOSTIC PRODUCTS CORP. 510(K)s with Product Code = DGC and Original Applicant = DPC CIRRUS
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