Recall Z-0701-2022 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
| Date | Jun 6, 2017 |
| Status | Terminated |
| Reason | Real-time shelf life testing failed at 24 months |
| Root cause | Process design |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.