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Terminated

Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)

FDA Recall Z-0224-2009 · Posted 2008-10-31

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCFR
Date Initiated2008-09-10
Date Terminated2009-11-27
Product Quantity8

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.

K002199MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SETPointe Scientific, Inc., · 2000-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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