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

Recall Z-2311-2016 — AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Ampheta

U.S. FDA — Device Enforcement · United States · 2016-07-05 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2311-2016
Date of alert: 2016-07-05
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Branan Medical Corporation
Product category: device
Product type: Devices

Reported risk: Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.

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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