Radar · device · signal

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811Recall or enforcement action

Complete coverage checks before an early-window claim.

Statistical status

No screen yet

Receipt-date counts have not been screened.

Evidence score

—

Research priority weight, not a probability of causation or recovery.

Missing: none recorded

Competition

unknown

Observed in monitored channels only. Unknown is not zero.

Coverage unknown. Early-window label is blocked.

What changed

Qualitative review · notice
Enforcement report. This is a product action, not an injury count. The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
10/09/2026 · A recall may not involve the injury later investigated.
Read the source

Receipt dates are the reporting screen. Event dates are a separate, lag-sensitive series. They are not added together.

Basis	Window	Covered days	Reports	Expected	Fold	Complete

Unknown. Court and RECAP collectors are not in this release. Do not read a blank docket as zero lawsuits.

No firm pages or ad notes. Competition stays unknown until the panel records one.