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Open, Classified

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

FDA Recall Z-1371-2025 · Posted 2025-03-14

Recalling FirmMicrobiologics Inc
Recall StatusOpen, Classified
Product CodeOHQ
Date Initiated2025-02-20
Product Quantity6 units

Reason for Recall

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

Firm 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 [email protected] 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 [email protected] with questions or concerns. Collect calls may be made.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of TX. UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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