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Terminated

Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L.

FDA Recall Z-1331-06 · Posted 2006-08-03

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCFR
Date Initiated2006-06-07
Date Terminated2007-11-19
Product Quantity61 bottles

Reason for Recall

Product does not meet performance specifications through its labeled expiration period.

Firm Action

Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, China, Panama, Russia 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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