Recall Z-1077-2016
Siemens Healthcare Diagnostics, Inc · initiated February 4, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 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
Codes / lots: Lot codes/Exp Date: 87226A42 May 9, 2016; 55811 A42 May 9, 2016; 53650A42 May 9, 2016; 53624A42 May 9, 2016; 15612A43 November 27, 2016; 17909A43 November 27, 2016; 22868A43 November 27, 2016; 45084A43 November 27, 2016
Reason for recall
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-1077-2016
- Initiated
- February 4, 2016
- Posted by FDA
- March 8, 2016
- Terminated
- August 1, 2017
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 15224 (2-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
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1078-2016 Class II | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number:…ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | 02/04/2016Terminated |
| Z-1079-2016 Class II | Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog…ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | 02/04/2016Terminated |