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Microbiologics Inc Recall 89446

Description: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

Microbiologics Inc Recall 89446 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0700-2022
Event ID89446
Event DescriptionHelix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
Quantity1
Recall ReasonReal-time shelf life testing failed at 24 months
Device Classification20220309
Device Code InfoCatalog Number: HE0041N; Lot Number: HE0041N-102-1; UDI: 10845357042153
Center Classification Date20220301
Recall Initiation Date20170606
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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