Pointe Scientific G6PD Controls Kit configuration: 6 x 0 — Class II medical device recall Z-2487-2015
Terminated recall by Pointe Scientific, Inc., reported 2015-09-09, distributed nationwide. A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of th
| Recall number | Z-2487-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pointe Scientific, Inc., Canton, MI, United States |
| Recall initiated | 2015-05-19 |
| Classified | 2015-08-31 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, GR, IL, IT |
| Reason classes | specification failure |
| Lot numbers | 2015-11, 505801 |
| Model numbers | 7-G7583-CTL-L1, 7-G7583-CTL-L2, 7-G7583-CTL-L3, G7583-CTL |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2487-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.