Devices

Device Recall ACE AST Reagent Kits

Model / Serial
ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. || Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
Manufacturer
Alfa Wassermann, Inc.
1 Event
- Recall of Device Recall ACE AST Reagent Kits

Manufacturer

Alfa Wassermann, Inc.

Manufacturer Address
Alfa Wassermann, Inc., 4 Henderson Dr, West Caldwell NJ 07006-6608
Manufacturer Parent Company (2017)
Alfa Wassermann Inc
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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