Enzyme linked immunosorbent assay recall
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Why was Enzyme linked immunosorbent assay recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
***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
- Product
- Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 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.
- Recall date
- March 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)