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Terminated

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

FDA Recall Z-0860-2015 · Posted 2014-12-23

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-10-09
Date Terminated2017-03-16
Product Quantity10,515 units total

Reason for Recall

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

Firm Action

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

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041133MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZERBayer Healthcare, LLC · 2004-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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