C. difficile assay recalled over declining performance and false negative results
Meridian Bioscience is recalling 211 units of the Revogene C. difficile assay because affected lots show a decline in performance over time, which may lead to false-negative results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the firm states the assay may produce false-negative results, and no injuries are reported.
Plain-English summary
Revogene C. difficile, an in vitro diagnostic assay intended for use with the Revogene instrument, catalog number 410300, is being recalled by Meridian Bioscience Inc.
The affected lots show a decline in performance over time, which the firm states may lead to false-negative results.
The record lists 211 units carrying UDI-DI 00840733102349, from lots 410300U195, 410300U196, 410300U197 and 410300U201. Distribution was nationwide in the United States and to Italy. The FDA has classified the action as Class II.
A false negative result can leave an infection undetected. The enforcement record reports no injuries. Laboratories should follow Meridian's instructions.
The recalled product
- Product
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Manufacturer
- Meridian Bioscience Inc
- Category
- Medical Device — Diagnostic test
- Affected units
- 211
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 (5)
- UDI-DI: 00840733102349
- Lot Numbers: 410300U195
- 410300U196
- 410300U197
- 410300U201
Distribution
Distributed nationwide across the United States.
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