The Recall Desk
ModerateFDA (Devices)·Z-0827-2015·Announced 2014-12-24

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.

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, 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.
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

Distributed in 11 states:

Same manufacturer · JAS Diagnostics Inc.

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