ADVIA Centaur (including refurbished) recallZ-0859-2015 · Siemens Healthcare Diagnostics, Inc. · initiated Oct 9, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Recall details
- Recall number
- Z-0859-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 9, 2014
- Posted by the FDA
- Dec 23, 2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 10,515 units total
- Product code
- JJE
- FDA submissions
- K041133
- 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.
Product description
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Code information (models, lots, serial numbers)
Product Codes: 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011 and 10361012
Other devices under the same FDA submission
4 devices cleared under K041133 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ADVIA Centaur® XP Analyzer 10364455Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE243 reports
- ADVIA Centaur® XPT Analyzer 10711433Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE192 reports
- ADVIA Centaur® CP Immunoassay System 10309710Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE185 reports
- ADVIA Centaur® XP Analyzer 10471899Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE26 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 69582).
- Z-0860-2015 · TerminatedADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page