Siemens Healthcare Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-0365-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 24, 2013

Date Posted: November 27, 2013

Recall Number: Z-0365-2014

Event ID: 66396

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

Status: Terminated

Product Quantity: Domestic: 1191 units; Foreign: 3052 units

Code Information:

Lots 090445B (exp. 07/2014) and 090445C (exp. 10/2014)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated