FDA Devices recall · Reported September 9, 2015
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.
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 spec…
Pointe Scientific, Inc. recalled Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1,… - a moderate-severity action.
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1,… was recalled by Pointe Scientific, Inc. in September 9, 2015. Reason: A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of …. Check the official notice for the remedy. Verify recall #Z-2487-2015 with the FDA Devices before acting.
The recall
Pointe Scientific, Inc. issued this moderate-severity FDA Devices recall-A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of ….
- Moderate
- severity level
- Class II
- classification
- September 9, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2487-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2487-2015 |
| Date reported | September 9, 2015 |
| Date initiated | May 19, 2015 |
| Recalling firm | Pointe Scientific, Inc. |
| Firm location | Canton, MI |
| Affected scope | 2772 total vials (374 kits of 6 vials, 528 invidually sold vials) |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2487-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026