Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SM

FDA device recall Z-0365-2014 · posted 2013-11-19 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

Reason for recall

Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of

Action taken

Siemens Healthcare Diagnostics sent an Urgent Medical Device Correction Letters dated September 24, 2013 and Response Forms to the US consignees via FedEx. Urgent Field Safety Notices were also distributed to customers outside the US. Customers are instructed to use the reassigned System Specific Values for the affected lots listed in the letter. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within thirty (30) days. The questionnaire is to be faxed to the Technical Solutions Center at 302-631-7597. On September 30, 2013, Siemens sent a revised customer notifications to correct the Part Number.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CIG

Quantity affected

Domestic: 1191 units; Foreign: 3052 units

Distribution

Worldwide Distribution - USA Nationwide in the states of: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, French Polyne

Date initiated

2013-09-24

Date posted

2013-11-19

Date terminated

2018-05-17

Location

Tarrytown, NY

Related 510(k) clearances