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Device defect recalls

Recalls tagged “Device defect”, newest first. Company page 3 recalls Each recall is dated by the day its recall page names (how recalls are dated).
Agency
Risk level
Status
Date
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1 recall that day

bioMérieux VITEK 2 AST-N461 Test Kit

The Vitek 2 AST-N461 test kit may give false resistant results due to card pouch damage, potentially leading to less effective antibiotic treatments.

Moderate risk, FDA, Device defect

1 recall that day

Vitek 2 AST-N447 Test Kit

The Vitek 2 AST-N447 test kit may give false resistant results when pouch foil is fractured.

Moderate risk, FDA, Device defect

1 recall that day

VITEK 2 Gram-negative Susceptibility Cards

Issue may lead to QC failure or false resistant results.

Moderate risk, FDA, Device defect