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.
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.
Part of a larger recall action
This product is one of 16 recalled by bioMerieux, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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