Siemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.
What this means for you
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, but the source text describes a potential for increased imprecision in quality control and patient samples without reporting specific adverse health consequences, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,004 units of Syva EMIT 2000 Theophylline reagent, specifically lot G3 (Catalog # 4P019UL / SMN#10445324). The recall also involves the ADVIA Chemistry Theophylline_2 (THEO_2) reagent, lot 334018. These products are homogeneous enzyme immunoassays intended for the quantitative analysis of theophylline in human serum or plasma.
The recall was initiated because the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophylline_2 reagent lot 334018, may exhibit increased imprecision. This issue specifically affects results when using commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples.
The affected products were distributed to laboratories 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
- Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,004
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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