Lower riskMedical device recall · FDA · Published October 8, 2020
Microbiologics Catalog 02145P: VIM-1 Negative Risk in Microbial Testing Controls
Microbiologics recalls Catalog 02145P bacterial controls for microbial testing due to incorrect VIM-1 status. These controls may not verify assay performance properly.
“Microbiologics Catalog 02145P: VIM-1 Negative Risk in Microbial Testing Controls.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64107-microbiologics-catalog-02145p-vim-1-negative-risk-in-microbial-testing. Based on FDA recall #Z-0402-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0402-2021%22&limit=1).
The FDA announced on Oct. 8, 2020, that Microbiologics Inc is recalling Catalog 02145P Klebsiella pneumoniae controls because the strain is confirmed VIM-1 negative instead of positive. The agency issued recall number Z-0402-2021 for the Class II voluntary recall.
The strain should be VIM-1 positive but is confirmed to be VIM-1 negative. The product is intended to be used as controls to verify the performance of assays, reagents or media for microbial testing.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls include a Dec. 2, 2025 KWIK-STIK 6-Pack recall for microorganism recovery failure and a Nov. 13, 2025 KWIK-STIK Quality Control Kit recall for lot labeling mix-ups. Similar products have faced issues, including a Jan. 5, 2026 Biomerieux VITEK 2 Gram-negative Susceptibility Cards recall for false antibiotic results and a Dec. 5, 2025 Meridian Bioscience Revogene C. difficile Test recall for false-negative risk.
How to tell if you have this one
Check for the product name 'Catalog 02145P' or similar bacterial controls from Microbiologics. Look for lot numbers 1245-03-1 through 1245-04-1 on the packaging.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name and lot numbers on the packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0402-2021 (October 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0402-2021 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.