The Recall Desk
HighFDA (Devices)·Z-0425-2022·Announced 2022-01-05

VIDAS diagnostic test for C. difficile recalled due to substrate defect

bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.

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 an FDA Class II recall of a diagnostic test with a substrate defect that prevents proper operation. Although no illnesses or injuries have been reported, the malfunction of a diagnostic test for C. difficile toxins represents a potential risk of harm through delayed or missed diagnoses.

Plain-English summary

The product being recalled is the VIDAS Clostridium difficile Toxin A&B (CDAB) diagnostic test, manufactured by bioMerieux, Inc. This test is used in clinical laboratories to detect C. difficile toxins in patient samples.

bioMerieux has received an increasing number of complaints about a substrate error in some units of this test. The substrate error prevents the test from running, resulting in delayed test results as the laboratory must run another test.

The affected product has been distributed nationwide in the United States. Lot #1008730880 is identified as affected.

Laboratories currently using this product should contact bioMerieux if they experience this substrate error.

The recalled product

Product
VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
Manufacturer
bioMerieux, Inc.
Category
Medical Device — In Vitro Diagnostic Test
Hazard
  • test-malfunction
  • delayed-diagnosis

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 03573026229146
  • Lot #s: 1008730880

Distribution

Distributed nationwide across the United States.

Related recalls

Same category