FDA Device

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.

Hazard

Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.

What You Should Do

Remedy

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.

Products

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.
Brand
Abbott Laboratories
UPC
Barcode numbers Starting with SYR-S12E-, and ending with 0066, 0074, 0078, 0079, 0097, 0100, 0244, 0130, 0134, 0144, 0145, 0146, 0147, 0245, 0148, 0153, 0211, 0213, 0216, 0217, 0247, 0218, 0222, 0224, 0225, 0232, 0234, 0248, 0235, 0236, 0237, 0239, 0240, and 0243.

Units Affected

30 syringes