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.
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 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…
- 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Microbiologics Inc
See all →- ModerateCampylobacter control kits recalled because they may fail to recover the organism
FDA (Devices) · 2025-12-31
- ModerateCampylobacter six-pack control kits recalled over failure to recover the organism
FDA (Devices) · 2025-12-31
- ModerateCampylobacter LYFO DISK controls recalled over failure to recover the organism
FDA (Devices) · 2025-12-31
- ModerateCulture media quality control kits recalled over mislabeled lot numbers on pouches
FDA (Devices) · 2025-12-10
- ModerateLYFO-DISK M. canis single packs may fail to recover the organism
FDA (Devices) · 2025-08-06
Same hazard · mis labeling
See all →- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
Similar recalls
- HighKWIK-STIK Quality Control Sets recalled for potential bacterial contamination
FDA (Devices) · 2022-02-16
- ModerateMicrobiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling
FDA (Devices) · 2022-02-16
- ModerateMicrobiologics Recalls KWIK-STIK Trichosporon Dermatis Culture Pack
FDA (Devices) · 2020-04-15
- ModerateMicrobiologics QC Sets Recalled for Potential Mislabeling of Fungal Strains
FDA (Devices) · 2020-04-15
- ModerateMedical device reference standard contaminated with bacterial species
FDA (Devices) · 2022-02-16
- ModerateMedical device control product pouches mislabeled with incorrect catalog number
FDA (Devices) · 2022-02-09