Recalls / —
—#132219
Product
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
- FDA product code
- JQP — Calculator/Data Processing Module, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- CentraLink" Data Management System V14x Catalog Numbers: 10817209, 10818262
Why it was recalled
Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
A Siemens service provider visited each site to verify and/or update customer configuration on the ADVIA Chemistry XPT and CentraLink Systems to ensure proper reporting of results. An Urgent Medical Device Correction letter was issued on December 16, 2014 to all affected customers. Customers were also provided a Customer Bulletin providing instructions on how configuration setting should remain.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Distributed in the state of WA.
Timeline
- Recall initiated
- 2014-12-16
- Posted by FDA
- 2015-01-15
- Terminated
- 2016-10-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #132219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.