Recall Z-0827-2015 ยท CFR Hexokinase, Glucose
JAS Diagnostics Inc.
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
| Date | Dec 18, 2014 (initiated Oct 23, 2014) |
| Status | Terminated |
| Reason | Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range. |
| Root cause | Under Investigation by 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. |
| Quantity | 390 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011900 | GLUCOSE (HEXOKINASE) Jas Diagnostics, Inc., Jul 31, 2001 |