Devices

Synchron Phenobarbital (PHE) Drug Calibrator 1

Model / Serial
M810440 and earlier
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution--USA (nationwide) and the country of Canada.
Product Description
Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, || Classification Product Code: KLT. || Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. || The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Synchron Phenobarbital (PHE) Drug Calibrator 1

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
Manufacturer Parent Company (2017)
Danaher Corporation
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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