Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure
Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The failure is a quality control issue (positive negative control) rather than a reported injury or death, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Advandx Inc is recalling 10 kits of the AdvanDx Quick FISH Fixation Kit for BC (Blood Cultures), catalog number QFFixBC1-50. This in vitro diagnostic component is used with the Staphylococcus QuickFISH BC test. The specific lot number is 04914, with an expiration date of June 2015.
The recall was initiated because the product failed quality control testing. Specifically, a positive result was observed in the internal negative control well for the Staphylococcus QuickFISH BC test. This indicates a potential issue with the reliability of the test results.
The affected kits were distributed in the states of Arizona, Idaho, Florida, Missouri, Ohio, Michigan, New Jersey, and Virginia. Users of this product should stop using the affected kits and contact Advandx Inc for further instructions or a replacement.
The recalled product
- Product
- AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
- Manufacturer
- Advandx Inc
- Affected units
- 10
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 (1)
- Lot Number: 04914 Exp. Date: 2015-06
Distribution
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