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

Recall Z-2196-2013 — DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439

U.S. FDA — Device Enforcement · United States · 2013-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2196-2013
Date of alert: 2013-07-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Assuramed
Product category: device
Product type: Devices

Reported risk: The products may have been stored at temperatures outside their required storage conditions.

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

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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