ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog numbe

FDA device recall Z-1960-2014 · posted 2014-07-02 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).

Action taken

Siemens Healthcare sent an Urgent Field Safety Notice that was sent to all affected Siemens Healthcare Diagnostics customers in the United States on June 25, 2013. The Urgent Field Safety Notice was sent out for distribution to all customers outside the United States on June 24, 2013. These notices inform the customer that the 1:10 diluted patient recovery is lower than reported in the Instructions for Use (IFU). Customers should discontinue use of both manual and on board 1:10 dilutions of samples with the ADVIA Centaur HCY assay. Customers can continue to use a manual or on board 1 :2 dilution for samples with results outside of the assay range. Siemens has confirmed the performance at the 1 :2 dilution level meets the IFU ranges. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Technical Solutions Center or your local Siemens technical support representative. For further questions please call (508) 668-5000.

Root cause

Device Design

Status

Terminated

Product code

LPS

Quantity affected

51 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland

Date initiated

2013-06-25

Date posted

2014-07-02

Date terminated

2016-05-31

Location

East Walpole, MA

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