BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV)

FDA device recall Z-2429-2018 · posted 2018-05-09 · Terminated

Recall details

Recalling firm

bioMerieux, Inc.

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.

Action taken

Subsidiaries and distributors were initially notified of the recall on approximately 01/04/2018. U.S. customers were notified via letter on approximately 01/22/2018. On 03/28/2018 a follow-up notification was issued world-wide to customers to expand the scope. Instructions included to increase the frequency of the Quality Control VIDAS (QCV) testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed, continue to conduct a visual inspection of the SPR after each run (including patient sample test and QCV test) to ensure that the dot on the SPR is still in place, continue to perform External QC testing in accordance with laboratory policy and in compliance with Governmental Regulations & Accreditation Requirements, which includes CLIA, ensure the notification letter is distributed to and reviewed by all appropriate personnel, store the notification letter with the bioMrieux VIDAS and /or miniVIDAS documentation, and complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of the notice. For further questions, please call (314) 731-8694

Root cause

Device Design

Status

Terminated

Product code

JJE

Quantity affected

1,866 units

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, PA,

Date initiated

2018-01-04

Date posted

2018-05-09

Date terminated

2022-04-14

Location

Durham, NC

Related 510(k) clearances