ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525,
FDA device recall Z-2662-2014 · posted 2014-09-18 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- Reason for recall
- The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.
- Action taken
- The firm, Siemens, sent "Urgent Medical Device Correction" Letters (dated 8/13/2014) to their consignees/customers informing them of the issue and actions to be taken. Field service personnel were sent a Support Bulletin describing the issue and instructing them how to deal with customer questions. The UFSN must be used by customers as an addendum to the system operating instructions until further notice. The consignees/customers were also instructed to review this letter with your Medical Director; complete and return the attached FIELD CORRECTION EFFECTIVENESS CHECK within 30 days via fax to the Customer Care Center at (302) 631-7597; retain the letter with your laboratory records and forward the letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center, your local Siemens technical support representative and/or call 914-524-2868.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 10,515 (Domestic: 2771; Foreign: 7744) in total
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republ
- Date initiated
- 2014-08-13
- Date posted
- 2014-09-18
- Date terminated
- 2017-05-02
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133) | Bayer Healthcare, LLC | 2004-07-02 |