Z-1274-2021Class II

Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

Name: Z-1274-2021 Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2021-02-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-02-08 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 on 2021-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1274-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-08
Posted: 2021-03-18
Terminated: 2025-02-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Product code: MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: ***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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1274-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1274-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-18

Product code MYF

K181334Class IIADVIA Centaur Herpes-2 IgGBiokit, S.A. / cleared 2018-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)