Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Culture Units
Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units that were confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a mislabeling/quality defect in a laboratory culture product with no reported injuries or illnesses, fitting the Moderate criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Microbiologics Inc is recalling KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P). The recall is due to a quality defect where the product was confirmed to be NDM-1 negative, whereas it should contain the NDM-1 positive strain.
The affected product consists of units containing a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. The specific lots involved are 1145-06-1, 1145-06-2, 1145-06-3, 1145-06-4, 1145-06-6, and 1145-07-1. The product was distributed in the US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and the United Kingdom.
Consumers and healthcare facilities should stop using the affected units and contact Microbiologics Inc for instructions on return or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog 01145P
- Lots 1145-06-1
- 1145-06-2
- 1145-06-3
- 1145-06-4
- 1145-06-6
- 1145-07-1 UDI: UDI: 20845357036807
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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