Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Due to Incorrect Strain
Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was 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: This is a Class II recall involving a labeling/identity error (incorrect strain) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Microbiologics Inc is recalling KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K). The recall is due to a quality issue where the product was confirmed to be NDM-1 negative, whereas it should contain the NDM-1 positive strain.
The affected product is a medical device containing a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. The specific lot identified is Lot 1145-06-5 with UDI 30845357036811. The product was distributed in the US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and the United Kingdom.
Users of this product should stop using the affected units and contact Microbiologics Inc for further instructions or a 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
- Affected units
- 1
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 (2)
- Catalog 01145K
- Lot 1145-06-5 UDI: 30845357036811
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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