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Terminated

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

FDA Recall Z-0827-2015 · Posted 2014-12-18

Recalling FirmJAS Diagnostics Inc.
Recall StatusTerminated
Product CodeCFR
Date Initiated2014-10-23
Date Terminated2015-02-26
Product Quantity390

Reason for Recall

Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.

Firm Action

On October 23, 2014, JAS Diagnostics, Inc. sent out an IMPORTANT PRODUCT RECALL INFORMATION letter asking its consignees to discontinue use of the Glucose Hexokinase lots immediately. Customers are to contact the Service Department at 305-748-2762 or 305-748-2763 for information regarding reimbursement. Also, customers are to complete the attached Certificate of Destruction and return the document to JAS Diagnostics.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.

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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