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Terminated

Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

FDA Recall Z-1873-2014 · Posted 2014-06-25

Recalling FirmJAS Diagnostics Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2014-04-07
Date Terminated2014-08-21
Product Quantity407

Reason for Recall

JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

Firm Action

JAS Diagnostics, Inc. sent an Important Product Recall Information letter dated April 7, 2014 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1) Screen their inventory for any of the lots listed in the letter and discontinue use immediately. 2) Contact the Customer Service Department at 305-748-2762 or 305-748-2763 to obtain replacement product.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011900GLUCOSE (HEXOKINASE)Jas Diagnostics, Inc. · 2001-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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