FDA Device recall Z-0103-2015
ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit by Siemens Healthcare Diagnostics, citing increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0103-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-15 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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 the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Reason
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
Identifiers
| code_info | Lot Number: 36217064, 36281064, 36449064, 37406064, 38177064 Exp.Date:February 10, 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0103-2015%22
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