Qualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results
Qualigen Inc is recalling specific lots of its Vitamin D Complete Immunoassay Kit because they may produce falsely low results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect medical diagnosis) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Qualigen Inc is recalling specific lots of the Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068. The recall involves 493 units distributed nationwide in the US and in Germany, Switzerland, Turkey, and the UAE. The affected lot numbers are 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P.
The recall was initiated because these specific lots have been reported to produce falsely lower than expected results for Vitamin D. This inaccuracy could lead to incorrect clinical interpretations of patient Vitamin D levels.
Healthcare facilities and laboratories should stop using the affected lots and contact Qualigen Inc for instructions on returning the product. Consumers should not use these kits for personal testing.
The recalled product
- Product
- Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
- Manufacturer
- Qualigen Inc
- Hazard
- Affected units
- 493
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 (4)
- Lot numbers: 1701033-3P
- 1701033-4P
- 1701033-5P
- and 1701033-6P
Distribution
Distributed nationwide across the United States.
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