• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 64610
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc
City East Walpole
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D. Lot Number: C3410 Kit Lot Number/Exp. Date: 95010A10 8/16/2013 Class II Negative bias in patient samples for Vitamin D 107 6pk Cals Z-1122-2013
ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D. Lot Number: C3410 Kit Lot Number/Exp. Date: 95197A10 8/16/2013 95031A10 8/16/2013 94607A10 8/16/2013 94155A10 8/16/2013 Class II Negative bias in patient samples for Vitamin D 372 pk Cals Z-1121-2013
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D. Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013 Class II Negative bias in patient samples for Vitamin D 4133 Z-1120-2013
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D. Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013 Class II Negative bias in patient samples for Vitamin D 3871 Z-1119-2013
-
-