Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0697-2022 — 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-311

U.S. FDA — Device Enforcement · United States · 2017-06-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0697-2022
Date of alert: 2017-06-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Microbiologics Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 70845357041240

Reported risk: Real-time shelf life testing failed at 24 months

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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