Siemens Recalls Theophylline Reagent Due to Increased Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Theophylline reagents because they may exhibit increased imprecision when used with certain quality control materials.
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. The hazard involves increased imprecision in diagnostic results rather than a direct physical injury or acute health threat, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 658 units of ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent, Lot # 334018. The company has confirmed that this reagent, along with Syva EMIT 2000 Theophylline reagent lot G3, may exhibit increased imprecision when run on a Beckman AU Clinical Chemistry System.
The recall is due to potential issues with commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples. The affected product is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on ADVIA Chemistry Systems.
The recalled units were distributed to facilities in California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Virginia, and Washington. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 658
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 (2)
- ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503
- Lot # 334018
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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