Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA device recall Z-0827-2015 · posted 2014-12-18 · Terminated
Recall details
- Recalling firm
- JAS Diagnostics Inc.
- Reason for recall
- Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.
- Action taken
- 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
- Status
- Terminated
- Product code
- CFR
- Quantity affected
- 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
- Date initiated
- 2014-10-23
- Date posted
- 2014-12-18
- Date terminated
- 2015-02-26
- Location
- Miami Lakes, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLUCOSE (HEXOKINASE) (K011900) | Jas Diagnostics, Inc. | 2001-07-31 |