Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
This recall is currently active, issued March 14, 2025. It was issued by Microbiologics Inc.
- Company
- Microbiologics Inc
- Recall Initiated
- February 20, 2025
- Posted
- March 14, 2025
- Recall Number
- Z-1371-2025
- Quantity
- 6 units
- Firm Location
- Saint Cloud, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Distribution
US Nationwide distribution in the states of TX. UK.
Lot / Code Info
UDI-DI: 10845357043563; Lot Number: HE0065-29
Root Cause
Process control
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.