Lin-Zhi Norbuprenorphine Calibrator Recalled for Quality Control Failure
Lin-Zhi International is recalling Norbuprenorphine cutoff calibrators because they failed quality control testing. The product is used for in vitro diagnostic calibration.
What this means for you
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. The issue is a quality control failure in a calibration standard, not a direct patient safety hazard like a device malfunction causing injury.
Plain-English summary
Lin-Zhi International Inc. is recalling 120 units of the Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator. The affected lots are 1308006 and 1308131, with an expiry date of March 28, 2015. The product is intended for in vitro diagnostic use only and is used for the qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay on the Synchron Clinical Analyzer.
The recall was initiated after a customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. Specifically, the calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL), rather than the expected cutoff level. This indicates a potential failure in the product's ability to perform its intended calibration function.
The affected units were distributed in the United States, including California. Users of this product should stop using the affected lots and contact Lin-Zhi International Inc. for further instructions or a replacement.
The recalled product
- Product
- 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
- Manufacturer
- Lin-Zhi International Inc
- Hazard
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 (5)
- Product catalog number: A68827
- Lots 1308006
- 1308131
- Expiry: March 28
- 2015.
Distribution
Distributed in 1 state:
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