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Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E-… recallZ-1079-2016 · Siemens Healthcare Diagnostics, Inc · initiated Feb 4, 2016

Class II Terminated All recalls posted in March 2016

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

ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens Healthcare issued an Urgent Medical Device Correction (UMDC) to all affected Siemens Healthcare Diagnostics customers in the United States on February 4, 2016 to be delivered to customers on February 5, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on February 4, 2016. These notices inform the customers of the lot to lot bias of Calibrator E with the ADVIA Centaur Testosterone assay and advise customers to move to Calibrator E kit lots ending in 44. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Correction. Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative

Recall details

Recall number
Z-1079-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 4, 2016
Posted by the FDA
Mar 8, 2016
Recalling firm
Siemens Healthcare Diagnostics, Inc
Quantity
519 pack
Product code
JIX
FDA submissions
K932955
Distribution
Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA

Product description

Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems

Code information (models, lots, serial numbers)

Lot codes/Exp Date: 91005A42 May 9, 2016; 53698A42 May 9, 2016

Other devices under the same FDA submission

4 devices cleared under K932955 — 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 73263).

Sources and updates

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