Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control
FDA device recall Z-1371-2025 · posted 2025-03-14 · Open, Classified
Recall details
- Recalling firm
- Microbiologics Inc
- Reason for recall
- The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OHQ
- Quantity affected
- 6 units
- Distribution
- US Nationwide distribution in the states of TX. UK.
- Date initiated
- 2025-02-20
- Date posted
- 2025-03-14
- Location
- Saint Cloud, MN
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