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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 IgG see related information
Date Initiated by Firm February 08, 2021
Date Posted March 18, 2021
Recall Status1 Open3, Classified
Recall Number Z-1274-2021
Recall Event ID 87381
510(K)Number K181334  
Product Classification Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 - Product Code MYF
Product Enzyme 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     
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact Louise 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
Action In 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 Commerce 390 kits total (Domestic 366 kits, Foreign 24 kits)
Distribution Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MYF and Original Applicant = Biokit, S.A.
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