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ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro… recallZ-0103-2015 · Siemens Healthcare Diagnostics, Inc · initiated Sep 15, 2014

Class II Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

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.

Recall details

Recall number
Z-0103-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 15, 2014
Posted by the FDA
Oct 21, 2014
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
5434
Product code
LOM
FDA submissions
P040004
Distribution
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.

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.

Code information (models, lots, serial numbers)

Lot Number:  36217064, 36281064, 36449064, 37406064, 38177064  Exp.Date:February 10, 2015

Other devices under the same FDA submission

2 devices cleared under P040004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69292).

Sources and updates

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