—#75708

Product

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 product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K051215
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Worldwide Distribution -- USA, Australia, Canada, and Germany.

Timeline

Recall initiated: 2008-12-10
Posted by FDA: 2009-04-23
Terminated: 2010-12-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75708. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.