FDA-Device2015-09-09Class II
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.
Pointe Scientific, Inc.
Hazard
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.
Sold states
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.
Affected count
2772 total vials (374 kits of 6 vials, 528 invidually sold vials)
Manufactured in
5449 Research Dr, N/A, Canton, MI, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2487-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief