The Recall Desk
HighFDA (Devices)·Z-0435-2022·Announced 2022-01-05

VIDAS Estradiol II Test Device Recalled Due to Substrate Error

bioMerieux is recalling one lot of VIDAS Estradiol II diagnostic test devices due to a substrate error that prevents tests from running, causing delayed results and requiring repeat testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a substrate error that prevents test execution and potentially delays diagnostic results. No illnesses or injuries have been reported, but the defect affects a risk-of-harm product (diagnostic testing), meeting the criteria for Score 3 under the rubric.

Plain-English summary

bioMerieux, Inc. is recalling one lot of VIDAS Estradiol II (REF 30431-01) diagnostic test devices due to a substrate error in the devices. The substrate error prevents the test from being run. Users who attempt to use affected devices cannot obtain test results without repeating the test, resulting in delayed diagnostic results. The affected lot (Lot #1008757880, UDI 03573026161637) was distributed nationwide throughout the United States.

The recalled product

Product
VIDAS Estradiol II, REF 30431-01
Manufacturer
bioMerieux, Inc.
Category
Medical Device — Diagnostic Test Device
Hazard
  • substrate-defect
  • test-failure

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 (2)

  • UDI 03573026161637
  • Lot #: 1008757880

Distribution

Distributed nationwide across the United States.

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