Tosoh G8 Automated HPLC Analyzer Recalled for Missing 510(k) Software
Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).
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, which typically indicates a moderate risk. The source text cites a regulatory compliance issue (missing 510(k) software) rather than a specific physical hazard or reported injury, aligning with the 'Moderate' criteria for voluntary or regulatory recalls without immediate harm reports.
Plain-English summary
Tosoh Bioscience Inc is recalling eight units of the G8 Automated HPLC Analyzer (Model 723G8). The recall is due to the analyzers being distributed with software that lacks a 510(k) clearance.
The affected devices are used for in vitro diagnostic purposes to quantitatively measure hemoglobin A1c in whole blood specimens. This test serves as an aid in the diagnosis of diabetes and in identifying patients at risk for developing the condition.
The recall covers units distributed in California, Oklahoma, Virginia, and Wisconsin. Affected serial numbers include 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212, and 14917201. Users should contact the manufacturer for further instructions.
The recalled product
- Product
- G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk…
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 8
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)
- Serial Numbers: 14646304
- 14917201
- 14886112
- 14616503
- 14856212
- 14887601
- 14886212 & 14917201
Distribution
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