Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA.
FDA Recall Z-1069-2009 · Posted 2009-04-23
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Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2008-12-10
Date Terminated2010-12-27
Product Quantity30 syringes
Reason for Recall
Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
Firm Action
Recall initiated on December 10, 2008. A product recall letter and reply form were cent to CELL-DYN Sapphire customers who received syringes between September 16, 2008 and October 28, 2008 to US customers, and to November 5, 2008 for Outside-of-US customers.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, Australia, Canada, and Germany.
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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