Techno-Path Multichem AE Quality Control Material Recalled for Stability Drift
Techno-Path is recalling Multichem AE Unassayed Level 3 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Class II, and the source states that delayed diagnosis of elevated Ammonia levels may impact the 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 Techno-Path Multichem AE Unassayed Level 3, REF:AE623X. The recall is limited to Lot # 65705263, which was distributed nationwide in the state of Massachusetts.
Routine stability studies identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of the Multichem AE quality control material. 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 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 recalled product
- Product
- Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
- 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)05391523442824/-Lot # 65705263
Distribution
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