Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision
Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate diagnostic results) where specific injury or illness has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Systems HBc Total (HBcT) Reagent, catalog number 07566733, lot number 100064, with an expiration date of February 10, 2015. The product is an in vitro diagnostic test used for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus in human serum or plasma.
The recall was initiated because increased imprecision and positive bias were observed with patient samples and negative controls. This performance issue can result in an increase in initial reactive results, potentially leading to inaccurate diagnostic outcomes.
The affected units were distributed worldwide, including the United States and various countries in Europe, the Middle East, and Asia. Users of the ADVIA Centaur and ADVIA Centaur XP systems should stop using the affected reagent and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. 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…
- 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 (2)
- Lot Number: 100064 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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