Recalls / —
—#143654
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
- FDA product code
- JIX — Calibrator, Multi-Analyte Mixture
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K932955
- Affected lot / code info
- Lot codes/Exp Date: 91005A42 May 9, 2016; 53698A42 May 9, 2016
Why it was recalled
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc
- Address
- 333 Coney St, East Walpole, Massachusetts 02032-1516
Distribution
- Distribution pattern
- 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
Timeline
- Recall initiated
- 2016-02-04
- Posted by FDA
- 2016-03-08
- Terminated
- 2017-08-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #143654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.