RecallDepth

Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (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-0221-2009
Quantity
10
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

HG720-600 lots 727501-303, 727501-355 and 727501-127. HG920-756 lot 727501-112.

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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