Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) Recalled by Siemens Healthcare Diagnostics, Inc. Due to Firm has received complaints from customers of "Abnormal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
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.
Quantity: 959 cartons
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report