Siemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision
Siemens is recalling ADVIA Centaur HBc Total kits due to increased imprecision and positive bias that may cause false reactive 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 high-risk diagnostic product where the defect (positive bias) can lead to incorrect clinical decisions, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,434 units of the ADVIA Centaur Systems HBc Total (HBcT) Kit, Catalog Number 07566733. The affected lots are 36217064, 36281064, 36449064, 37406064, and 38177064, all with an expiration date of February 10, 2015. The product was distributed nationwide in the United States and in numerous countries worldwide, including Austria, Germany, France, and the United Kingdom.
The recall was initiated because increased imprecision and positive bias were observed with patient samples and negative controls. This defect can result in an increase in initial reactive results, potentially leading to inaccurate diagnostic outcomes for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus.
Healthcare facilities and laboratories that have received these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 5,434
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 (6)
- Lot Number: 36217064
- 36281064
- 36449064
- 37406064
- 38177064 Exp.Date:February 10
- 2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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