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
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0699-2022 |
| Event ID | 89446 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide 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. |
| Quantity | 1 unit |
| Recall Reason | Real-time shelf life testing failed at 24 months |
| Device Classification | 20220309 |
| Device Code Info | Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023 |
| Center Classification Date | 20220301 |
| Recall Initiation Date | 20170606 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
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