Microgenics Recalls CEDIA Tobramycin II Assay Due to Calibration Stability Issues
Microgenics Corp. is recalling CEDIA Tobramycin II Assay (Lot 60169764) due to a calibration stability problem identified through two customer complaints.
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. The hazard involves a calibration stability issue identified via complaints, without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Microgenics Corp., part of Thermo Fisher Scientific, is recalling the CEDIA Tobramycin II Assay, Catalog Number 100018. The specific lot affected is 60169764. This in vitro diagnostic medical device is intended for the quantitation of Tobramycin in human serum or plasma.
The recall was initiated due to a calibration stability problem. This issue was identified following the receipt of two complaints regarding the product's performance.
The affected units were distributed worldwide, including in the United States (specifically Wisconsin, Utah, North Dakota, Montana, Washington, California, and Oklahoma) and internationally to Australia, Canada, and Germany. A total of 370 units are involved in this recall. Users should stop using the affected lot and contact the manufacturer for further instructions.
The recalled product
- Product
- Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic…
- Manufacturer
- Microgenics Corp
- Hazard
- Affected units
- 370
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: 60169764
Distribution
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