JAS Diagnostics Recalls Glucose Hexokinase Reagent Due to Performance Issues
JAS Diagnostics Inc. is recalling 390 units of Glucose Hexokinase (Liquid) Reagent because the product does not perform according to specifications.
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, and the source text describes a performance defect without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
JAS Diagnostics Inc. is recalling 390 units of Glucose Hexokinase (Liquid) Reagent, which is used for the in vitro quantitative determination of glucose in serum. The recall was initiated because the product is not performing according to specifications, specifically because Control 2 does not consistently recover within its assigned range.
The affected lots were distributed worldwide, including in the United States (specifically NV, TN, TX, FL, GA, NY, NC, CA, MN, OR, and Puerto Rico) and in France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana. The specific lot numbers and expiration dates are listed in the structured product information.
Healthcare facilities and laboratories should stop using the affected reagent and contact JAS Diagnostics Inc. for instructions on returning the product.
The recalled product
- Product
- Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
- Manufacturer
- JAS Diagnostics Inc.
- Affected units
- 390
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 (20)
- Lot: N0702011K
- Exp. 10/2014
- N0702012
- N0702013K
- P010201K
- Exp. 04/2015
- P010202K
- P010203K
- P010204K
- P010205K
- P010206K
- P0402015K
- Exp. 07/2015
- P0402016K
- P050207K
- Exp. 08/2015
- P050208K
- P050209K
- P0502010K
- P0502011K
Distribution
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