Recall Z-0859-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
| Date | Dec 23, 2014 (initiated Oct 9, 2014) |
| Status | Terminated |
| Reason | 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 |
| Action | A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. |
| Quantity | 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, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER Bayer Healthcare, LLC, Jul 2, 2004 |