Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
This recall is currently active, issued March 25, 2025. It was issued by Microbiologics Inc.
- Company
- Microbiologics Inc
- Recall Initiated
- February 20, 2025
- Posted
- March 25, 2025
- Recall Number
- Z-1454-2025
- Quantity
- 28 units
- Firm Location
- Saint Cloud, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The RSV target may give a late Ct value and could potentially not pass QC.
Distribution
Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
Lot / Code Info
UDI-DI: 10845357042184; Lot Number: HE0044-131
Root Cause
Nonconforming Material/Component
Action Taken
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. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.