Microbiologics Recalls KWIK-STIK 2 Pack Due to Incorrect NDM-1 Strain
Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.
What this means for you
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 labeling/identity error in a quality control product rather than a direct patient safety risk like a pathogen or structural defect, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
Microbiologics Inc is recalling specific units of the KWIK-STIK 2 Pack (Catalog# 5226P). The recall involves lots 5226-03, 5226-04, 5226-05, 5226-06, and 5226-07, identified by UDI 70845357037335. The affected products were distributed in the US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and the United Kingdom.
The recall was initiated because the KWIK-STIK 2 Pack units were confirmed to be NDM-1 negative, whereas they should contain the NDM-1 positive strain. This discrepancy affects the intended use of the quality control sets and panels.
Consumers and healthcare facilities 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 f
- Manufacturer
- Microbiologics Inc
- Category
- Medical Device — Quality Control
- Hazard
- Affected units
- 5
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 (6)
- Catalog 5226P
- Lots 5226-03
- 5226-04
- 5226-05
- 5226-06
- 5226-07 UDI: 70845357037335
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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