Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-2500 and 12-HG920-144. (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-0222-2009
- Quantity
- 37
- 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
HG920-1200 lots 727501-021 and 727501-203; HG920-2500 lot 727501-015; and 12-HG920-144 lots 727501-080 and 727501-142..
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.