Devices

Device Recall Pointe Scientific Iron Reagent (R2)

Model / Serial
All lot numbers containing the numbers 735401 or 816501.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad, Turkey, Ukraine and Venezuela.
Product Description
Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: 8HI904-R2-100.
Manufacturer
Pointe Scientific, Inc.
1 Event
- Recall of Device Recall Pointe Scientific Iron Reagent (R2)

Manufacturer

Pointe Scientific, Inc.

Manufacturer Address
Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
Manufacturer Parent Company (2017)
MedTest Holdings
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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