Medical Device Recall: Z-0103-2015

FDA Recalls dataset · Firm: Siemens Healthcare Diagnostics, Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2014-09-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0103-2015.

Recall Res Number
Z-0103-2015
Recalling Firm / Manufacturer
Siemens Healthcare Diagnostics, Inc
FEI Number
1219913
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2014-09-15
Date Posted
2014-10-21
Date Terminated
2015-12-28
Product Code
LOM
Event Number
69292
Product Quantity
5434
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.
Action Details Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Each customer will be required to return a completed confirmation fax-back to Siemens.
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
Code Information / Serial Numbers Lot Number:  36217064, 36281064, 36449064, 37406064, 38177064  Exp.Date:February 10, 2015

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