Quantimetrix Recalls Dropper Plus Urinalysis Control Kits Due to Lot Error
Quantimetrix Corporation is recalling 20 kits of Dropper Plus Point-of-Care Urinalysis Dipstick Control because they contained an incorrect lot of Level 1 vials.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/lot error rather than a direct safety hazard like contamination or malfunction.
Plain-English summary
Quantimetrix Corporation is recalling 20 kits of the Dropper Plus Point-of-Care Urinalysis Dipstick Control. The recall was initiated because the kits contained an incorrect lot of Dropper Plus Level 1 vials.
The affected product is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods, as well as for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods. The specific lot number for the affected kits is 44450E.
The product was distributed in the United States to the state of Kansas. No specific consumer instructions are provided in the source text beyond the identification of the recall.
The recalled product
- Product
- Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for…
- Manufacturer
- Quantimetrix Corporation
- Hazard
- Affected units
- 20
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 44450E
Distribution
Distributed in 1 state:
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