Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
This recall has been terminated (originally issued November 19, 2013).
- Company
- Siemens Healthcare Diagnostics
- Recall Initiated
- September 24, 2013
- Posted
- November 19, 2013
- Terminated
- May 17, 2018
- Recall Number
- Z-0365-2014
- Quantity
- Domestic: 1191 units; Foreign: 3052 units
- Firm Location
- Tarrytown, NY
- Official Source
- View on FDA website ↗
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
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 Polynesia, Germany, Guadeloupe, Guatemala, Great Britain, Greece, Korea, Indonesia, Israel, Italy, Kazakhstan, Latvia, Liechstenstein, Lithuania, Luxembourg, Macedonia, Martinique, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovenia, Slovakia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, and Vietnam.
Lot / Code Info
Lots 090445B (exp. 07/2014) and 090445C (exp. 10/2014)
Root Cause
Under Investigation by firm
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.