FDA Device recall Z-2428-2018
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automat…
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automat… by Biomerieux, citing increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2428-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-04 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.
Reason
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.
Identifiers
| code_info | Description, Reference No. (UDI No.): MINI VIDAS ANALYSER EU, 99174 (03573026111021); MINI VIDAS ANALYSER US, 99175 (0…Description, Reference No. (UDI No.): MINI VIDAS ANALYSER EU, 99174 (03573026111021); MINI VIDAS ANALYSER US, 99175 (03573026111045); MINI VIDAS 100-120 VOLT VDE/CE, 99733 (03573026118662); MINI VIDAS 200-240 VOLT VDE/CE, 99734 (03573026118655); MINI VIDAS BLUE 110 / 220 V, 99737 (03573026140441); MINI VIDAS ARKRAY ANALYZER, 99739 (03573026140465); MINI VIDAS, 410416 (03573026351656); MINI VIDAS, W1421 (03573026029180); MINIVIDAS INDUSTRY US, 421001 (03573026553319) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2428-2018%22
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