Siemens Dimension Vista Theophylline Cartridge Recalled for Abnormal Reaction Errors
Siemens Healthcare Diagnostics is recalling Dimension Vista Theophylline cartridges due to 'Abnormal Reaction' errors triggered by atypical particle reagent aggregation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error ('Abnormal Reaction' flag) without reporting any patient injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions where harm has not been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 959 cartons of Dimension Vista Systems Vista Theophylline THEO Flex Regent Cartridges (K4071). The affected lots are 12135AE and 12171BB. These products are in vitro diagnostic tests used for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista system.
The recall was initiated after the firm received customer complaints regarding 'Abnormal Reaction' errors occurring during calibrations, quality control, and patient sample testing. According to the source text, the Abnormal Reaction flag is triggered by an internal check in the method for atypical particle reagent aggregation.
The affected products were distributed nationwide in the United States, 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. Users should stop using the affected cartridges and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 959
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 12135AE and 12171BB
Distribution
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