FDA Device Recall Z-0072-2017: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0072-2017.

Recall Res Number

Z-0072-2017

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2432235

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-04-28

Date Posted

N/A

Date Terminated

2018-06-07

Product Code

JLW

Event Number

74162

Product Quantity

292 units Total (3 domestically & 289 internationally)

Product Description ADVIA Centaur XPT Immunoassay System

Reason for Recall The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.

Action Details Siemens sent an Urgent Medical Device Correction letter dated April 28, 2016, to all affected customers. The letter advised customers not to release results generated by the system if quality control results are not within acceptable ranges. Customers were advised to perform the following steps to check the Setting for the Daily Maintenance Task frequency on your instrument: *Open the Maintenance Tab, * Select Daily Maintenance task and * Verify that the Frequency Column is set to "Daily at..". The Daily Maintenance Task frequency setting can only be reset by a Siemens Customer Service engineer. If your instrument is set to "As Needed": Daily Maintenance Task Frequency Setting May be Incorrect. Customers should contact their local Technical Support Center to schedule a visit by your Siemens Customer Service engineer. Customers should also perform the daily maintenance by selecting the Daily Maintenance Task and then selecting Perform on the right bar. In addition, all customers were asked to complete and return the Field Correction Effectiveness Check within 30 days. For questions regarding this recall call 914-631-8000.

Distribution Pattern Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN

Code Information / Serial Numbers None

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Medical Device Recall: Z-0072-2017

Recall Parameters & Description

Related Establishments / Registrations

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