Microbiologics QC Sets: Shelf Life Testing Failed at 24 Months
Microbiologics recalls Helix Elite Extended Enteric Bacterial Verification Panels due to real-time shelf life testing failure at 24 months. No remedy specified in official notice.
Recall notice
Real-time shelf life testing failed at 24 months
Contact the company
What happened, in plain English
Microbiologics is recalling their Helix Elite Extended Enteric Bacterial Verification Panels because shelf life testing failed at 24 months. This means the product may not be safe for use after this period, though the specific risk isn't detailed in the recall. Read more at govinfonow.com/recall/73934-microbiologics-qc-sets-shelf-life-testing-failed-at-24-months.
Source Summary by GovInfoNow · govinfonow.com/recall/73934-microbiologics-qc-sets-shelf-life-testing-failed-at-24-months · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0697-2022
Cite this page
“Microbiologics QC Sets: Shelf Life Testing Failed at 24 Months.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73934-microbiologics-qc-sets-shelf-life-testing-failed-at-24-months. Based on FDA recall #Z-0697-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0697-2022%22&limit=1).
Why it’s dangerous
The recall states that real-time shelf life testing failed at 24 months. This suggests the product may degrade or become unsafe after this period, but the exact hazard mechanism isn't specified in the notice.
Who’s affected
Users of the Helix Elite Extended Enteric Bacterial Verification Panels (Catalog Number 8191) are affected. Laboratory personnel handling these panels are most at risk.
How to tell if you have this one
Check for the Helix Elite Extended Enteric Bacterial Verification Panels with Catalog Number 8191 and Lot Number 8191-01. The unique device identifier (UDI) is 70845357041240.
- Brand
Microbiologics- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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-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; Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240 | 8 units |
| Z-0698-2022 | Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.; Catalog Number: 8193; Lot Number: 8193-04, 8193-06; UDI: 70845357041080 | 29 units |
| Z-0699-2022 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.; Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023 | 1 unit |
| Z-0700-2022 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.; Catalog Number: HE0041N; Lot Number: HE0041N-102-1; UDI: 10845357042153 | 1 |
| Z-0701-2022 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus; Catalog Number: HE0044N; Lot Number: HE0044N-103-1; UDI: 10845357042184 | 1 unit |
What to do — step by step
Check Product Details
Look for the Catalog Number 8191 and Lot Number 8191-01 on the panel packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 22 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, California, District of Columbia, Florida, Idaho, Iowa, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 5.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of injury from this product?
The recall does not describe any specific injury risk, so the danger level is unknown.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0697-2022 (June 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0697-2022 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.