Devices

Device Recall Pointe Scientific G6PD Screening Controls

Model / Serial
Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.
Product Description
Pointe Scientific G6PD Controls || Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). || Also sold as individual vials || Bottle: Clear glass vials || Cap: Rubber seal with colored aluminum seals || Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
Manufacturer
Pointe Scientific, Inc.
1 Event
- Recall of Device Recall Pointe Scientific G6PD Screening Controls

Manufacturer

Pointe Scientific, Inc.

Manufacturer Address
Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
Manufacturer Parent Company (2017)
Medtest Holdings 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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