ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tes
FDA device recall Z-0860-2015 · posted 2014-12-23 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
- Action taken
- A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 10,515 units total
- Distribution
- Nationwide Distribution including PR and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, P
- Date initiated
- 2014-10-09
- Date posted
- 2014-12-23
- Date terminated
- 2017-03-16
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133) | Bayer Healthcare, LLC | 2004-07-02 |