JAS Diagnostics Recalls Glucose Hexokinase Reagent Lots for Performance Issues
JAS Diagnostics Inc. is recalling specific lots of Glucose Hexokinase Liquid Reagent because they do 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 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. The hazard involves a medical device not performing to specifications, which poses a risk of harm (incorrect test results) but the source does not report specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
JAS Diagnostics Inc. of Miami Lakes, Florida, is recalling 407 units of Glucose Hexokinase Liquid Reagent. This product is used for the in vitro quantitative determination of glucose in serum. The recall is due to certain lots not performing according to their specifications.
The affected lots are N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, and N1102029K. The products were distributed worldwide, including in the United States (specifically Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ, and WV) and in the countries of Barbados, Ghana, Trinidad, Tobago, Canada, and Haiti.
This recall is classified as Class II by the FDA. Users should check their inventory for the listed lot numbers and stop using the affected reagents. The source text does not specify further consumer actions or report any illnesses or injuries.
The recalled product
- Product
- Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
- Manufacturer
- JAS Diagnostics Inc.
- Hazard
- Affected units
- 407
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 (19)
- LOTS#: N060208K
- N060209K
- N0602010K
- N0902014K
- N0902015K
- N0902016K
- N0902017K
- N0902018K
- N0902019K
- N0902020K
- N1102021K
- N1102022K
- N1102023K
- N1102024K
- N1102025K
- N1102026K
- N1102027K
- N1102028K
- N1102029K.
Distribution
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