—#130991

Product

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

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K041133
Affected lot / code info: Product Codes: 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696 and 10471899.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-10-09
Posted by FDA: 2014-12-23
Terminated: 2017-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130991. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.