ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit

FDA device recall Z-1119-2013 · posted 2013-04-15 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Negative bias in patient samples for Vitamin D

Action taken

Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.

Root cause

No Marketing Application

Status

Terminated

Product code

MRG

Quantity affected

3871

Distribution

Nationwide Distribution.

Date initiated

2013-03-13

Date posted

2013-04-15

Date terminated

2015-03-05

Location

East Walpole, MA