Date Initiated by Firm | February 04, 2016 |
Date Posted | March 08, 2016 |
Recall Status1 |
Terminated 3 on August 01, 2017 |
Recall Number | Z-1079-2016 |
Recall Event ID |
73263 |
510(K)Number | K932955 |
Product Classification |
Calibrator, multi-analyte mixture - Product Code JIX
|
Product | 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 |
Lot codes/Exp Date: 91005A42 May 9, 2016; 53698A42 May 9, 2016 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
|
For Additional Information Contact | SAME 508-668-5000 |
Manufacturer Reason for Recall | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay |
FDA Determined Cause 2 | Under Investigation by firm |
Action | 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 |
Quantity in Commerce | 519 pack |
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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JIX
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