Pointe Scientific, Inc. Recall: Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5
Pointe Scientific, Inc. Recall: Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Pointe Scientific, Inc.; Product: Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Als
| Recalling firm | Pointe Scientific, Inc. |
|---|---|
| Product | 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. |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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. |
| Recall initiated | 20150519 |
| Recall number | Z-2487-2015 |
| Category | device |
| State | MI |
| Country | United States |
$29/mo
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