Sentinel CH Recalls MULTIGENT Creatinine Reagents Due to Quality Control Issues
Sentinel CH SPA is recalling MULTIGENT Creatinine (Enzymatic) reagents because Reagent 1 may cause quality control values to shift out of acceptable range.
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 quality control shifts that are not resolved by recalibration, but the source text does not report any specific patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sentinel CH SPA is recalling specific lots of MULTIGENT Creatinine (Enzymatic) in vitro diagnostic (IVD) reagents. The affected products are intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The recall includes Catalog Numbers 8L24-31 and 8L24-41, with specific lot numbers and expiration dates of 2018-02-28.
The recall is being conducted because the Reagent 1 component may result in quality control values shifting out of the acceptable range. The source text notes that this issue is not resolved by recalibration. The recall covers 2,356 kits worldwide, including 206 kits in the United States, which were distributed nationwide.
Healthcare facilities and laboratories should stop using the affected lots immediately. Users should contact Sentinel CH SPA for further instructions on how to return or dispose of the product.
The recalled product
- Product
- MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quan
- Manufacturer
- Sentinel CH SPA
- Hazard
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)
- Catalog Number 8L24-31: Lot Numbers: 60335Y600
- 60382Y600 (Exp. Date 2018-02-28)
- Catalog Number 8L24-41: Lot Number: 60334Y600
- (Exp. Date 2018-02-28)
Distribution
Distributed nationwide across the United States.
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