Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2487-2015 — 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

U.S. FDA — Device Enforcement · United States · 2015-05-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2487-2015
Date of alert: 2015-05-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Pointe Scientific, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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