Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml Recalled by Pointe Scientific, Inc. Due to A reduction in the reconstituted stability has been...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pointe Scientific, Inc. directly.
Affected Products
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.
Quantity: 2772 total vials (374 kits of 6 vials, 528 invidually sold vials)
Why Was This Recalled?
A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pointe Scientific, Inc.
Pointe Scientific, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report