Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays whe
FDA device recall Z-2313-2012 · posted 2012-09-06 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
- Action taken
- Siemens sent an "URGENT DEVICE RECALL NOTICE" dated July 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Response Form was included for customers to complete and return via fax to (302) 631-7597. Contact your local Sales Representative for questions regarding this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NBC
- Quantity affected
- 2 Packs = 15879 and 6 Packs = 7414
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japa
- Date initiated
- 2012-07-25
- Date posted
- 2012-09-06
- Date terminated
- 2015-11-04
- Location
- East Walpole, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA CENTAUR TSH3-ULTRA METHOD (K083844) | Siemens Healthcare Diagnostics | 2009-05-08 |
| ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K031038) | Bayer Healthcare, LLC | 2003-06-23 |