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.
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. 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
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02