Integrated Science Systems Recalls Sure Vue Staph Identification Kits
Integrated Science Systems is recalling Sure Vue Staph kits due to customer complaints of weak reactions and false negative results.
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, and the hazard involves diagnostic accuracy (false negatives) rather than direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk issues or precautionary measures.
Plain-English summary
Integrated Science Systems Inc is recalling 2,625 kits of Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, and biokit SELECT Staph 75T. These products are used as an aid in the identification of Staphylococcus aureus from culture.
The recall was initiated due to customer complaints reporting very weak reactions with the kit or false negative results when testing different Staphylococcus aureus cultures. The affected lot numbers are KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, and KJ12043.
The products were distributed nationwide to California only. Users should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
- Manufacturer
- Integrated Science Systems Inc
- Affected units
- 2,625
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 (20)
- Lot Numbers - KJ05016
- KJ05017
- KJ05018
- KJ06019
- KJ06020
- KJ06021
- KJ07023
- KJ10028
- J06022
- KJ07024
- KJ07025
- KJ09026
- KJ09027
- KJ10029
- KJ10030
- KJ11034
- KJ11035
- KJ12040
- KJ12041
- KJ12042
Distribution
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