Recall Z-1454-2025 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
| Date | Mar 25, 2025 (initiated Feb 20, 2025) |
| Status | Open, Classified |
| Reason | The RSV target may give a late Ct value and could potentially not pass QC. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall notification letter dated 2/20/25 was sent to customers. INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Pleas |
| Quantity | 28 units |
| Distribution | Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.