Lin-Zhi International Recalls Ethyl Alcohol Enzymatic Assay Kits
Lin-Zhi International Inc is recalling 49 Ethyl Alcohol Enzymatic Assay kits due to potential detergent contamination that may reduce shelf life.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and the issue is limited to reduced shelf life due to degradation.
Plain-English summary
Lin-Zhi International Inc is recalling 49 units of the Ethyl Alcohol Enzymatic Assay, including small test kits (REF 0220, Lot Code 1810026) and large test kits (REF 0221, Lot Code 1810025). The recall is due to the possibility that containers or pitchers with detergent residue were used during the production of the affected lot, which causes faster degradation of the assay.
The affected products were distributed nationwide in the United States, specifically in California, Massachusetts, Georgia, Kentucky, North Carolina, Michigan, Maryland, Connecticut, Arizona, South Carolina, Tennessee, and Oregon. The shelf life of the product may be reduced due to this degradation.
Consumers who have these specific lot numbers should stop using the kits and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
- Manufacturer
- Lin-Zhi International Inc
- Hazard
- Affected units
- 49
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 (3)
- (a) REF 0220 (small test kit)
- Lot Code 1810026 (b) REF 0221 (large test kit)
- Lot Code 1810025
Distribution
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