Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator Recalled by Lin-Zhi International Inc Due to Customer reported that the Synchron NBUP cutoff calibrator...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Lin-Zhi International Inc directly.
Affected Products
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
Quantity: 120 units, 60 of each lot number
Why Was This Recalled?
Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
Where Was This Sold?
This product was distributed to 1 state: CA
About Lin-Zhi International Inc
Lin-Zhi International Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report