ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: 09427226 (128532) 100 test kit

FDA device recall Z-1477-2011 · posted 2011-03-02 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal

Action taken

Siemens Healthcare Diagnostics on 12 /14/10 issued Urgent Device Recall notice via Federal Express to accounts. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Device Recall notice directs customers to immediately discontinue the use of ADVIA Centaur CA 125 II assay kits that contain CA 125 II reagent lot 144. It also recommends that patient results obtained with this reagent lot be reviewed. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Technical questions, please contact the Technical Solutions Center at 1-877-229-3711

Root cause

Process control

Status

Terminated

Product code

LTK

Quantity affected

2960 units

Distribution

Worldwide distribution, including USA, Canada, Argentina, Austria, Belgium, China, Denmark, France, Germany, Great Britain, Greece, India, Italy, Japan, Korea, Lavitia, Lithuania, Malyasia, Mexico, Ne

Date initiated

2010-12-14

Date posted

2011-03-02

Date terminated

2013-04-12

Location

East Walpole, MA

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