Lin-Zhi International Recalls Norbuprenorphine Urine Control Material
Lin-Zhi International is recalling Norbuprenorphine Level 2 Controls because the analyte degrades, causing decreased concentration readings.
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 by definition is unlikely to cause adverse health consequences. The issue is a degradation of the analyte affecting test precision rather than a direct safety hazard to patients.
Plain-English summary
Lin-Zhi International, Inc. is recalling 60 items of Single Analyte Urine DAU Control (Norbuprenorphine, Level II control). The product is intended for in vitro diagnostic use to monitor the precision of the Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer.
The recall was initiated because the Norbuprenorphine analyte in the solution degrades, which results in a decreased concentration reading. The affected product is identified by Catalog #A68825, Lot #1307086, and has an expiration date of 3/28/2014.
The product was distributed in California. Users of this quality control material should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International…
- Manufacturer
- Lin-Zhi International Inc
- Affected units
- 60
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)
- Catalog #A68825
- Lot #1307086
- Exp. 3/28/2014/
Distribution
Distributed in 1 state:
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