Siemens HSV-2 Test Kits Recalled for Potential False Positive Results
Siemens is recalling ADVIA Centaur4P Herpes-2 IgG test kits due to stability and calibration failures that may cause false positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (false positive diagnostic results) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur4P Herpes-2 IgG (HSV2) test kits. The recall involves 390 kits total, with 366 distributed domestically in the United States and 24 distributed in foreign countries including Nepal, Chile, Georgia, and Spain. The affected lots are B33255, B33269, and B33413.
The recall was initiated to correct Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System. These technical failures may result in potential false positive results for Herpes Simplex Virus type 2 (HSV-2).
Healthcare facilities and laboratories that have received these kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions. Consumers who have received test results from these specific kits should consult their healthcare provider to discuss the potential for false positives.
The recalled product
- Product
- Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- ***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
Distribution
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