Recall Z-1873-2014 ยท CGA Glucose Oxidase, Glucose
JAS Diagnostics Inc.
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
| Date | Jun 25, 2014 (initiated Apr 7, 2014) |
| Status | Terminated |
| Reason | JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications. |
| Root cause | Mixed-up of materials/components |
| 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. |
| Quantity | 407 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011900 | GLUCOSE (HEXOKINASE) Jas Diagnostics, Inc., Jul 31, 2001 |