ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Numbe

FDA device recall Z-0103-2015 · posted 2014-10-21 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Action taken

Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Each customer will be required to return a completed confirmation fax-back to Siemens.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LOM

Quantity affected

5434

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Ital

Date initiated

2014-09-15

Date posted

2014-10-21

Date terminated

2015-12-28

Location

East Walpole, MA