Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)
This recall has been terminated (originally issued October 31, 2008).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- September 10, 2008
- Posted
- October 31, 2008
- Terminated
- November 27, 2009
- Recall Number
- Z-0224-2009
- Quantity
- 8
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The inability of the product to maintain stated performance specifications through the stated shelf life.
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Lot / Code Info
Lots 727501-008 and 727501-233.
Root Cause
Process control
Action Taken
Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.
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