Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Recalled by Microbiologics Inc Due to Real-time shelf life testing failed at 24 months

Date: June 6, 2017
Company: Microbiologics Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Microbiologics Inc directly.

Affected Products

Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209

Quantity: 8 units

Why Was This Recalled?

Real-time shelf life testing failed at 24 months

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Microbiologics Inc

Microbiologics Inc has 66 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report