Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-2500 and 12-HG920-144. (Clinical chemistry)
FDA Recall Z-0222-2009 · Posted 2008-10-31
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Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCFR
Date Initiated2008-09-10
Date Terminated2009-11-27
Product Quantity37
Reason for Recall
The inability of the product to maintain stated performance specifications through the stated shelf life.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationwide, Canada, China, Romania and Trinidad.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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