ADVIA Centaur¿¿ Systems HBc Total — Class II medical device recall Z-0103-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-10-29, distributed nationwide. Increased imprecision and positive bias is observed with patient samples and negative controls and can result
| Recall number | Z-0103-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2014-09-15 |
| Classified | 2014-10-21 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-12-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BH, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IQ, IT, JO, LB, LT, LU, LV, NL, NO, PL, PT, RO, SE, SK, TR |
| Quantity | 5,434 |
| Lot numbers | 36217064, 36281064, 36449064, 37406064, 38177064 |
| Model numbers | 07566733 |
| Expiration dates | 2015-02-10 |
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 for recall
Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.