Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 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
Reported: March 16, 2016 Initiated: February 4, 2016 #Z-1078-2016
Product Description
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 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
Reason for Recall
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 6455 (6 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
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 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. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 6455 (6 pack).
Why was this product recalled? ▼
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2016. Severity: Moderate. Recall number: Z-1078-2016.
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