Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 16, 2022
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubatio
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Microbiologics Inc recalled QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive … - a moderate-severity action.
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive … was recalled by Microbiologics Inc in February 16, 2022. Reason: Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.. Check the official notice for the remedy. Verify recall #Z-0584-2022 with the FDA Devices before acting.
The recall
Microbiologics Inc issued this moderate-severity FDA Devices recall-Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri..
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- February 16, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0584-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0584-2022) was formally reported on February 16, 2022, with the manufacturer initiating the action on October 1, 2020. 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 11 units.
The documented reason for this recall is: Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the cou…. 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
11 units
Related Recalls
6
3 from same agency
Product description
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.
Reason for recall
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0584-2022 |
| Date reported | February 16, 2022 |
| Date initiated | October 1, 2020 |
| Recalling firm | Microbiologics Inc |
| Firm location | Saint Cloud, MN |
| Affected scope | 11 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA,… |
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-0584-2022) 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? ▼
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.. Recalled by Microbiologics Inc. Units affected: 11 units.
Why was this product recalled? ▼
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 16, 2022. Severity: Moderate. Recall number: Z-0584-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, FRANCE, GEORGIA, GERMANY, GUATAMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, VIETNAM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0584-2022) 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 February 16, 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.