Techno-Path Multichem AE Quality Control Material Recalled for Stability Issues
Techno-Path is recalling Multichem AE quality control material because stability drift affects the Ammonia analyte, potentially delaying diagnostic results.
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 Class II due to stability drift in the Ammonia analyte, which may delay diagnostic results and impact timely treatment. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Techno-Path Manufacturing Ltd. is recalling 123 units of Multichem AE Unassayed Level 2 quality control material (REF: AE622X, Lot # 65705262). The recall was initiated after routine stability studies identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.
The affected product was distributed nationwide in the United States, specifically within the state of Massachusetts. The impacted device may cause a delay in issuing results to physicians. Delayed recognition and diagnosis of elevated levels may impact the timely treatment of life-threatening levels described within medical toxicity intervention decision points.
Consumers and healthcare facilities should stop using the affected lots and contact Techno-Path Manufacturing Ltd. for further instructions or a return.
The recalled product
- Product
- Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
- Manufacturer
- TECHNO-PATH MANUFACTURING LTD.
- Affected units
- 123
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)
- UDI:(01)05391523442817/Lot # 65705262
Distribution
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