Abbott Laboratories 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
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.
Products Sold
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.
Abbott Laboratories is recalling Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology due to Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026