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Microbiologics Inc Recall 89446

Description: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.

Microbiologics Inc Recall 89446 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0699-2022
Event ID89446
Event DescriptionHelix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.
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 unit
Recall ReasonReal-time shelf life testing failed at 24 months
Device Classification20220309
Device Code InfoCatalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023
Center Classification Date20220301
Recall Initiation Date20170606
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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