Devices

Device Recall Pointe Scientific Iron/TIBC Reagent Set

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/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10-I7504-60. || Clinical chemistry reagent for the quantitative determination of iron in serum.
Manufacturer
Pointe Scientific, Inc.
1 Event
- Recall of Device Recall Pointe Scientific Iron/TIBC Reagent Set

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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