Devices

Device Recall Waco Lipoprotein (a) Calibrator

Model / Serial
Lots Numbers-EK560 EXP 7/31/06 and EH213 EXP 9/30/06
Product Classification
Gastroenterology-Urology Devices
Device Class
3
Implanted device?
No
Distribution
The product was sold to one distributor and direct medical accounts Nationwide.
Product Description
Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan
Manufacturer
Wako Chemicals, USA Inc
1 Event
- Recall of Device Recall Waco Lipoprotein (a) Calibrator

Manufacturer

Wako Chemicals, USA Inc

Manufacturer Address
Wako Chemicals, USA Inc, 1600 Bellwood Road, Richmond VA 23237-1326
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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