Food, drugs, devices › bioMerieux, Inc.
Device recall: BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS
bioMerieux, Inc. (Durham, NC) initiated this device recall on 4 Jan 2018; FDA lists 2 product records under event 79993, classified Class II.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 14 Apr 2022. Initiation: voluntary: firm initiated. bioMerieux, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
bioMerieux, Inc., Durham, NC.
Reason for recall
"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."
Distribution
"Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2428-2018 | 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… | 1,866 units | Class II | Terminated | 18 Jul 2018 |
| Z-2429-2018 | BioMerieux 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… | 1,866 units | Class II | Terminated | 18 Jul 2018 |
Context
Other enforcement events for bioMerieux, Inc.
All 57 events for bioMerieux, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Apr 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.