RecallRadar

FDA Device recall Z-0860-2015

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

On 2014-12-31 the FDA classified a Class II recall of ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests by Siemens Healthcare Diagnostics, citing A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0860-2015
ClassificationClass II
Statusterminated
Initiated2014-10-09
Published2014-12-31
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

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

Reason

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

Identifiers

code_info
Product Codes: 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 1032…Product Codes: 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696 and 10471899.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0860-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.