Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed qu

FDA device recall Z-1454-2025 · posted 2025-03-25 · Open, Classified

Recall details

Recalling firm

Microbiologics Inc

Reason for recall

The RSV target may give a late Ct value and could potentially not pass QC.

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

Nonconforming Material/Component

Status

Open, Classified

Product code

OHQ

Quantity affected

28 units

Distribution

Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.

Date initiated

2025-02-20

Date posted

2025-03-25

Location

Saint Cloud, MN