HemoCue Hb 201 Microcuvettes Recalled for Punctured Packaging
HemoCue AB is recalling HemoCue Hb 201 Microcuvettes due to a production-related 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, but the source text describes a production-related packaging defect (punctured pouches) without reporting any illnesses, injuries, or specific high-risk hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
HemoCue AB is recalling HemoCue Hb 201 Microcuvettes because the company identified a production-related problem involving punctured single-pack pouches. The affected products are distributed worldwide, including in numerous U.S. states and international locations.
The recall involves specific part numbers and lot numbers of the microcuvettes. The source text does not specify the exact nature of the risk associated with the punctured pouches or report any illnesses or injuries. Consumers and healthcare providers should check their inventory for the affected lot numbers and contact HemoCue AB for further instructions.
The recalled product
- Product
- HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
- 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)
- Part Number 111715: Lot numbers1208655
- 1208658
- 1208659
- 1208660
- 1208663
- 1208664
- 1209667
- 1209669
- 1209670
- 1209671
- 1209672
- 1209674
- 1209675
- 1209677
- 1209678
- 1210681
- 1210683
- 1210685
- 1210688
- 1211690
Distribution
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