Syva EMIT 2000 Theophylline Assay Recalled for Increased Imprecision
Siemens Healthcare Diagnostics is recalling Lot J1 of the Syva EMIT 2000 Theophylline Assay because it may show increased imprecision when used with a Beckman AU Clinical Chemistry System.
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 source text describes a potential for increased imprecision but does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving potential diagnostic errors without confirmed harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Lot J1 of the Syva EMIT 2000 Theophylline Assay. The product is a homogeneous enzyme immunoassay intended for the quantitative analysis of theophylline in human serum or plasma. The recall is due to the potential for increased imprecision in results when the assay is run on a Beckman AU Clinical Chemistry System.
The affected product is identified by Catalog # 4P019UL /SMN#10445324 and UDI# 00842768001024J120190414. The recall covers US Nationwide Distribution. The source text does not specify the number of units affected or the specific dates of distribution.
Healthcare facilities and laboratories should stop using the affected lot and contact Siemens Healthcare Diagnostics for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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)
- Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)
Distribution
Distributed nationwide across the United States.
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