Terminated

VIDAS CMV IgM 30 Tests

FDA Recall Z-1408-2021 · Posted None

Recalling FirmBiomerieux Inc

Recall StatusTerminated

Product CodeLKQ

Date Initiated2021-03-16

Date Terminated2024-08-06

Product Quantity18705 kits

Reason for Recall

bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).

Firm Action

A Recall notification letter titled, "IMPORTANT: URGENT FIELD SAFETY NOTICE" was sent to the to the impacted subsidiaries and distributors on 03/16/2021 via email. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The recalling firm requested that the consignees conduct the following actions: 1 - Please distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred our product. 2 - Stop using and destroy any stock of lots VIDAS CMV IgM (Ref. 30205 and 30205-01) lots mentioned in Table 1 remaining in their inventory and not already discarded through the Urgent Field Safety notice related to FSCA#5087 3 - Complete the Acknowledgement Form in Attachment A and return it to their local bioMrieux representative to confirm receipt of this notice. 4 - Contact their local customer service if they have any questions.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed nationwide to NY, CA, IL, WV, NJ, NY, TX, IN, PA, WI, VA, GA, CO, MI, FL, OH, MA, LA, NV, MO, CT and internationally to Argentina, Australia, Belgium, Brazil, Switzerland, Chile, Colombia, Czech Republic, Germany, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, Hungary, India, Italy, Japan, South Korea, Mexico, Netherlands, Philippines, Poland, Portugal, Russian Fed., Sweden, Singapore, Thailand, Turkey, South Africa, Algeria, Angola, Bahrain, Belarus, Benin, Bolivia, Bosnia-Herz., Bulgaria, Burkina Faso, Cameroon, Cape Verde, Chad, Costa Rica, Croatia, Dem. Rep. Congo, Dominican Rep., Dutch Antilles, Ecuador, El Salvador, Georgia, Guatemala, Indonesia, Iran, Iraq, Israel, Kenya, Lebanon, Lithuania, Macedonia, Mali, Malta, Mongolia, Morocco, Mozambique, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sril Lanka, Syria, Tunisia, Uruguay, Utd.Arab Emir., Vietnam, Djibouti, Equatorial Guin, Zambia, Cap Verde

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933549VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc. · 1994-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.