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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Medical Solutions Diagnostics

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 Class 2 Device Recall Siemens Medical Solutions Diagnosticssee related information
Date Initiated by FirmJanuary 12, 2008
Date PostedMay 06, 2008
Recall Status1 Terminated 3 on June 20, 2012
Recall NumberZ-1119-2008
Recall Event ID 46346
510(K)NumberK971418 
PMA NumberP040018 
Product Classification in vitro diagnostic Hepatitis A - Product Code LOL
ProductADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.
Code Information All lots
FEI Number 1219913
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-359-3825
Manufacturer Reason
for Recall		Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSiemens issued a Urgent Field Safety Notiifcation (078D0709-01) to all Siemens Diagnostics Branches on 1/12/08 for communication to their customers. This Customer Bulletin/Urgent Field Safety Notification advises the customer of the problem and the actions to be taken to mitigate risk. A Confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action.
Quantity in Commerce49,533
DistributionWorldwide Distribution - USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
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 = LOL
PMA DatabasePMAs with Product Code = LOL
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