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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Herpes2 IgG

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 Class 2 Device Recall ADVIA Centaur Herpes2 IgGsee related information
Date Initiated by FirmFebruary 08, 2021
Date PostedMarch 18, 2021
Recall Status1 Terminated 3 on February 07, 2025
Recall NumberZ-1274-2021
Recall Event ID 87381
510(K)NumberK181334 
Product Classification Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 - Product Code MYF
ProductEnzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Code Information ***Updated as of 3/25/2021*** Lot #: B33255, B33269, B33413. UDI #:  (01)00630414016726(10)B33255(17)20210625,  (01)00630414016726(10)B33269(17)20210629, (01)00630414016726(10)B33413(17)20210819. Updated as of 3/25/2021     
FEI Number 1219913
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactLouise Mclaughlin
508-660-4381
Manufacturer Reason
for Recall		Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.
FDA Determined
Cause 2		Under Investigation by firm
ActionIn February 2021, Siemens will issue an Urgent Medical Device Correction notice to customers via letter stating that Siemens Healthcare Diagnostics Inc. has confirmed that the ADVIA Centaur HSV2 assay does not meet the 60 day onboard stability or the 28 day calibration frequency (interval) as stated in the ADVIA Centaur XP/XPT Herpes-2 IgG (HSV2).
Quantity in Commerce390 kits total (Domestic 366 kits, Foreign 24 kits)
DistributionDomestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
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 = MYF
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