PlainRecalls
FDA Devices Moderate Class II Terminated

ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.

Reported: December 31, 2014 Initiated: October 9, 2014 #Z-0860-2015

Product Description

ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.

Reason for Recall

A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

Details

Units 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, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled?
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 10,515 units total.
Why was this product recalled?
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 31, 2014. Severity: Moderate. Recall number: Z-0860-2015.