OPTI LION E-Plus Cassettes Recalled for Incorrect Barcode Labeling
OPTI Medical Systems is recalling OPTI LION E-Plus Cassettes because incorrect barcodes may affect performance over time and cause quality control failures.
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 does not report any hospitalizations, injuries, or deaths. The hazard is a labeling error affecting performance over time, which aligns with the 'Moderate' criteria for low-risk issues without reported harm.
Plain-English summary
OPTI Medical Systems, Inc. is recalling Model BP7507 OPTI LION E-Plus Cassettes. These cassettes are consumables used in the OPTI LION Electrolyte Analyzer to measure sodium, potassium, chloride, ionized calcium, and pH in whole blood, serum, and plasma samples. The recall involves 361 boxes of 25 cassettes each.
The cassettes were labeled with an incorrect barcode. This labeling error could affect the performance of one or more parameters as the product ages. Additionally, a distributor reported a customer complaint regarding quality control failures.
The affected lots are 252810, 315815, 319810, 319815, 321817, 367812, and 370812. The products were distributed worldwide, including nationwide in the United States (specifically noting CA, MA, MN, and VA) and in China, Guatemala, India, Iraq, South Korea, and the United Arab Emirates. Users should stop using the affected cassettes and contact the manufacturer for instructions.
The recalled product
- Product
- Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood…
- Manufacturer
- OPTI Medical Systems, Inc
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 (7)
- Lots 252810
- 315815
- 319810
- 319815
- 321817
- 367812
- 370812
Distribution
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