Recall Z-0103-2015— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-09-15, terminated 2015-12-28. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-15
- Terminated
- 2015-12-28
- Firm location
- East Walpole, MA, United States
Product description
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.
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