The Recall Desk
LowFDA (Devices)·Z-2311-2016·Announced 2016-08-10

Branan Medical Recalls AmediCheck Instant Test Cups Due to Packaging Error

Branan Medical is recalling AmediCheck Instant Test Cups because they may erroneously contain 12-panel cups due to a packaging error.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging error involving the wrong panel count, which is a documentation/packaging problem rather than a direct physical hazard.

Plain-English summary

Branan Medical Corporation is recalling the AmediCheck Instant Test Cup, Part No. C-C0501A-3A. This product is an in vitro diagnostic test used for the rapid detection of various drugs in human urine.

The recall was initiated because the 5-panel drug cups may erroneously contain 12-panel cups due to a packaging error. The affected units were distributed nationwide in the states of Tennessee, North Carolina, Florida, and Pennsylvania.

Consumers and healthcare providers should stop using the recalled test cups and contact Branan Medical Corporation for further instructions or a replacement.

The recalled product

Product
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 3
Affected units
96

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • T0858

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Branan Medical Corporation

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