HemoCue Urine Analyzer Recall for Missing Documentation
HemoCue AB is recalling 48 urine analyzers because they were shipped with the wrong Quick Reference Guide and a missing warranty statement.
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 and involves only documentation errors (incorrect guide and missing warranty) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation issues.
Plain-English summary
HemoCue AB is recalling 48 units of a portable urine analyzing system. The recall is due to a documentation error where an incorrect version of the Quick Reference Guide (QRG) was delivered with the products. Additionally, a warranty statement was missing from the analyzer package.
The affected devices were distributed in the states of Florida, Massachusetts, California, Oregon, New York, North Carolina, Missouri, Idaho, Indiana, Kentucky, Pennsylvania, Texas, Oklahoma, Illinois, Georgia, Kansas, and Utah. The source text does not specify the exact dates of distribution, though it notes the issue applies to shipments made from April 1, 2011, and onwards.
Consumers should check their serial numbers against the list provided by the firm to determine if their device is affected. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents…
- Manufacturer
- HemoCue AB
- Category
- Medical Device — Urine Analyzer
- Hazard
- Affected units
- 48
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)
- See serial numbers of affected devices in attachment profided by firm.
Distribution
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