Siemens IGF-I Reagent Recalled for Incubation Time Defect
Siemens Healthcare Diagnostics is recalling IGF-I reagents because the required incubation time for pretreatment solution equilibration is 24 minutes, not as previously indicated.
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 incorrect incubation timing which may lead to inaccurate test results, but the source text does not report any hospitalizations, serious injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 525 units of the IG1, IGF-I reagent (Catalog # LKGF1). This product is used for the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
The recall is due to a defect in the incubation requirements. The source text states that 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using the pretreatment solution (LGFA) contained in the kit. This specific timing requirement was not adequately communicated or reflected in the product instructions.
The affected units are identified by SMN Number 10381403, Lot 411, and an expiration date of 2016-04. The products were distributed domestically in Illinois, Florida, New York, Ohio, Louisiana, Missouri, and Massachusetts, as well as internationally in Canada and other locations. Users of this reagent should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 525
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)
- SMN Number:10381403 Lot: 411 Expired: 2016-04
Distribution
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