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.
What this means for you
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
Related recalls
Same manufacturer · HemoCue AB
See all →- ModerateHemoCue glucose microcuvettes experienced transit time outside of specified limits
FDA (Devices) · 2025-07-09
- ModerateHemoCue Urine Albumin Microcuvettes Recalled for Punctured Packaging
FDA (Devices) · 2013-11-06
- ModerateHemoCue Hb 201 Microcuvettes Recalled for Punctured Packaging
FDA (Devices) · 2013-11-06
- ModerateHemoCue Glucose 201 Microcuvettes Recalled for Punctured Packaging
FDA (Devices) · 2013-09-18
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02