Microbiologics KWIK-STIK 6-Pack Recall: NDM-1 Negative Microorganism Risk
Microbiolog: KWIK-STIK 6-pack units may contain NDM-1 negative Klebsiella pneumoniae instead of NDM-1 positive strain. This could lead to ineffective treatment for certain infections. Affected units have specific catalog and lot numbers.
Recall notice
KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
Contact the company
What happened, in plain English
Microbiologics is recalling KWIK-STIK 6-packs that may contain a different strain of Klebsiella pneumoniae than intended. This could mean the product won't work properly for some infections if used as directed. Read more at govinfonow.com/recall/64109-microbiologics-kwik-stik-6-pack-recall-ndm-1-negative-microorganism.
Source Summary by GovInfoNow · govinfonow.com/recall/64109-microbiologics-kwik-stik-6-pack-recall-ndm-1-negative-microorganism · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0303-2021
Cite this page
“Microbiologics KWIK-STIK 6-Pack Recall: NDM-1 Negative Microorganism Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64109-microbiologics-kwik-stik-6-pack-recall-ndm-1-negative-microorganism. Based on FDA recall #Z-0303-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0303-2021%22&limit=1).
Why it’s dangerous
The KWIK-STIK units are supposed to contain a specific NDM-1 positive strain of Klebsiella pneumoniae, but some units were confirmed to be NDM-1 negative. This could mean the product won't work as intended for certain infections, potentially leading to ineffective treatment.
Who’s affected
People using KWIK-STIK 6-packs for medical purposes, especially those with infections requiring specific bacterial strains. Healthcare providers and patients using the product are most at risk.
How to tell if you have this one
Check for the catalog number 01145K and lot number 1145-06-5 on the packaging. The product is sold in packs of 2 or 6 and has a unique identifier UDI: 30845357036811.
- Brand
Microbiologics- Category
Medical device
All 3 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
Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0302-2021 | 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 or 6.; Catalog 01145P, Lots 1145-06-1, 1145-06-2, 1145-06-3, 1145-06-4, 1145-06-6, 1145-07-1 UDI: UDI: 20845357036807 | 30 units |
| Z-0303-2021 | 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 or 6.; Catalog 01145K, Lot 1145-06-5 UDI: 30845357036811 | 1 unit |
| Z-0304-2021 | 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 or 6.; Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335 | 5 units |
What to do — step by step
Check Product Details
Look for catalog number 01145K and lot number 1145-06-5 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 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.
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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-0303-2021 (October 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0303-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.