HemoCue Urine Albumin Microcuvettes Recalled for Punctured Packaging
HemoCue AB is recalling Urine Albumin Microcuvettes due to a production issue causing punctured single-pack pouches.
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, and the hazard involves packaging integrity (punctured pouches) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
HemoCue AB is recalling HemoCue Urine Albumin Microcuvettes, which are used for the quantitative determination of albumin in human urine. The recall is due to a production-related problem involving punctured single-pack pouches.
The affected products are distributed worldwide, including in the United States and various international markets. The recall covers specific model numbers and lot numbers identified in the agency's records.
Consumers and healthcare providers should stop using the affected microcuvettes and contact HemoCue AB for further instructions or a replacement.
The recalled product
- Product
- HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative…
- Manufacturer
- HemoCue AB
- Hazard
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 (20)
- Model Number 110608 Lot Number: 1210865
- 1210873
- 1211878
- 1301893
- 1302810
- 1303836
- 1304838
- 1304840 and 1304842. Model Number 110610 Lot Number: 1209857
- 1210870
- 1211874
- 1211879
- 1212885
- 1301803
- 1302817 and 1302818. Model Number 110611 Lot Number: 1208848
- 1208853
- 1208854
- 1209855
- 1209856
- 1209858
- 1209860
Distribution
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