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

Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 5 — recall Z-0330-2017

U.S. FDA — Device Enforcement · United States · 2016-08-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0330-2017
Date of alert: 2016-08-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Azer Scientific, Inc.
Product category: device
Product type: Devices

Reported risk: Out of Specification Microbiological test results

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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