Recall Z-1069-2009
Abbott Laboratories · initiated December 10, 2008
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.
Codes / lots: 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.
Reason for recall
Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1069-2009
- Initiated
- December 10, 2008
- Posted by FDA
- April 23, 2009
- Terminated
- December 27, 2010
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 30 syringes
- Distribution
- Worldwide Distribution -- USA, Australia, Canada, and Germany.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA