Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 9, 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. par
Real-time shelf life testing failed at 24 months
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Microbiologics Inc recalled Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification P… - a moderate-severity action.
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification P… was recalled by Microbiologics Inc in March 9, 2022. Reason: Real-time shelf life testing failed at 24 months. Check the official notice for the remedy. Verify recall #Z-0697-2022 with the FDA Devices before acting.
The recall
Microbiologics Inc issued this moderate-severity FDA Devices recall-Real-time shelf life testing failed at 24 months.
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- March 9, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0697-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0697-2022) was formally reported on March 9, 2022, with the manufacturer initiating the action on June 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Microbiologics Inc is listed as the recalling firm, operating out of Saint Cloud, MN. Federal records list the affected scope as 8 units.
The documented reason for this recall is: Real-time shelf life testing failed at 24 months Distribution data in the federal record shows the product reached: 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, Uni…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8 units
Related Recalls
6
3 from same agency
Product description
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
Reason for recall
Real-time shelf life testing failed at 24 months
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0697-2022 |
| Date reported | March 9, 2022 |
| Date initiated | June 6, 2017 |
| Recalling firm | Microbiologics Inc |
| Firm location | Saint Cloud, MN |
| Affected scope | 8 units |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0697-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Microbiologics Inc. Units affected: 8 units.
Why was this product recalled? ▼
Real-time shelf life testing failed at 24 months
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0697-2022.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0697-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 9, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.