Devices

Device Recall Hemoglobin Reagent Syringe (CELLDYN Sapphire)

Model / Serial
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.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Australia, Canada, and Germany.
Product Description
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.
Manufacturer
Abbott Laboratories
1 Event
- Recall of Device Recall Hemoglobin Reagent Syringe (CELLDYN Sapphire)

Manufacturer

Abbott Laboratories

Manufacturer Address
Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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