Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0408-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.

Product Classification:

Class II

Date Initiated: August 9, 2012

Date Posted: November 28, 2012

Recall Number: Z-0408-2013

Event ID: 62835

Reason for Recall:

Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.

Status: Terminated

Product Quantity: 959 cartons

Code Information:

Lots 12135AE and 12171BB

Distribution Pattern:

USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated