Recall Z-0699-2022
Microbiologics Inc · initiated June 6, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 2C-25C 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.
Codes / lots: Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023
Reason for recall
Real-time shelf life testing failed at 24 months
FDA-determined cause: Process design
Action taken
Microbiologics notified customers on about 06/06/2017 via email containing a letter. The letters indicated the affected products and instructed customers to update their records with the corrected expiration date, which was provided for each affected lot.
Details
- Recall number
- Z-0699-2022
- Initiated
- June 6, 2017
- Terminated
- January 17, 2023
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 1 unit
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0697-2022 Class II | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0698-2022 Class II | Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel.…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0700-2022 Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |
| Z-0701-2022 Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and…Real-time shelf life testing failed at 24 months | 06/06/2017Terminated |