Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro dia

FDA device recall Z-0512-2013 · posted 2012-12-11 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

Action taken

Siemens Healthcare issued An Urgent Medical Device Correction Notice (for US customers) and an Urgent Field Safety Notice (for customers outside the US) dated November 5, 2012, to all affected customers. These notices inform customers who used the ADVIA Centaur BNP, BR, CA 19-9, Digitoxin, Folate, and Theophylline 2 assays to reduce their instrument operating temperature range to 20 -25 degrees C and for the DHEAS assay to reduce the instrument operating temperature range to 18 -26 degrees C when these assays are being used. These notices also direct customers to review the contents of the correction notice with their Laboratory Director or Medical Director. A confirmation fax-back form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local technical support representative. For questions regarding this recall call 508-668-5000.

Root cause

Device Design

Status

Terminated

Product code

KLS

Quantity affected

50 test=2397 and 250 test= 594

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Repub

Date initiated

2012-11-14

Date posted

2012-12-11

Date terminated

2015-09-25

Location

East Walpole, MA

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