Gentian Cystatin C Calibrator Recall for Inaccurate High Measurements
Gentian AS is recalling Cystatin C calibrators that may measure incorrect high values, potentially leading to falsely elevated patient results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect patient measurements) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Gentian AS is recalling specific lots of GENTIAN Cystatin C Calibrator and Calibrator Kit products. The recall involves 107 calibrator kits distributed in Minnesota, Virginia, and Kansas. The affected products include the Gentian C E, Cystatin C Calibrator (REF 1012), the Gentian C E Calibrator Kit (REF 1051), and the Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit (REF 1051). The recall covers lot numbers 1905415, 1904404, 1904403, and 1809403.
The firm identified that these calibrators have shown incorrect high values over time compared to the assigned values when released for distribution. This defect could result in higher Cystatin C values being measured in patients, potentially affecting clinical decision-making.
Healthcare facilities and laboratories that have received these products should stop using the affected calibrators and contact Gentian AS for further instructions on return or replacement. Consumers should not use these products for home testing, as they are intended for professional laboratory use.
The recalled product
- Product
- GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763…
- Manufacturer
- Gentian AS
- Hazard
- Affected units
- 107
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 (4)
- Lot numbers #s: 1905415
- 1904404
- 1904403
- 1809403
Distribution
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