Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent, or 1 x 2 L R1 x 500 ml R2, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers HG920-1200 and HG920-2500.
FDA Recall Z-1329-06 · Posted 2006-08-03
Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCFR
Date Initiated2006-06-07
Date Terminated2007-11-19
Product Quantity153 kits
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.