Techno-Path Multichem AE Quality Control Material Recalled for Stability Drift
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a quality control material with a stability drift in the Ammonia analyte that may delay diagnostic results and impact timely treatment of life-threatening levels. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Techno-Path Manufacturing Ltd. is recalling 832 units of Multichem AE Unassayed Level 1 quality control material (REF:AE621X). The recall is due to a stability drift identified in routine stability studies that affects 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 the physician. Delayed recognition and diagnosis of elevated levels may impact the timely treatment of life-threatening levels described within medical toxicity intervention decision points.
The source does not report any illnesses, injuries, or deaths associated with this recall. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
- Manufacturer
- TECHNO-PATH MANUFACTURING LTD.
- Affected units
- 832
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)05391523442800/Lot # 65705261
Distribution
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