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Microbiologics Inc Recall 89401

Description: LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

Microbiologics Inc Recall 89401 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0586-2022
Event ID89401
Event DescriptionLYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Product TypeDevices
DistributionWorldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Quantity1,726 units
Recall ReasonTests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
Device Classification20220216
Device Code InfoShared Lot Number (Expiration Date) with Product 1: 959-92-1 (10/31/2019), 959-92-2 (10/31/2019), 959-92-3 (10/31/2019), 959-92-4 (10/31/2019), 959-92-5 (10/31/2019), 959-92-6 (10/31/2019), 959-93-1 (02/29/2020), 959-93-2 (02/29/2020), 959-93-3 (02/29/2020), 959-93-4 (02/29/2020), 959-93-5 (02/29/2020), 959-93-6 (02/29/2020), 959-93-7 (02/29/2020). Specific codes for Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-94-1 (04/30/2020), 959-94-4 (04/30/2020), 959-95-3 (09/30/2020), 959-96-2 (12/31/2020), 959-97-3 (03/31/2021).
Center Classification Date20220208
Recall Initiation Date20200218
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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