Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur
FDA device recall Z-1077-2016 · posted 2016-03-08 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
- 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
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 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
- Date initiated
- 2016-02-04
- Date posted
- 2016-03-08
- Date terminated
- 2017-08-01
- Location
- East Walpole, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIBA CORNING ACS PROGESTERONE IMMUNOASSAY (K932955) | Ciba Corning Diagnostics Corp. | 1993-08-02 |