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Biomerieux Inc Recall 87555

Description: VIDAS¿ CMV IgM 30 Tests

Biomerieux Inc Recall 87555 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1408-2021
Event ID87555
Event DescriptionVIDAS¿ CMV IgM 30 Tests
Product TypeDevices
DistributionDistributed 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
Quantity18705 kits
Recall ReasonbioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
Device Classification20210421
Device Code Inforef 30205; lot numbers 1008143230 (exp. date: 04 MAY 2021), 1008182270 (exp. date: 26 MAY 2021), 1008363970 (exp. date: 01 SEP 2021), 1008433580 (exp. date: 15 OCT 2021) US ref 30205-01; lot numbers 1008143260 (exp. date: 04 MAY 2021) and 1008363980 (exp. date: 01 SEP 2021)
Center Classification Date20210410
Recall Initiation Date20210316
Recalling FirmBiomerieux Inc
Initial Notification E-Mail
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