FDA Medical Device Recalls (openFDA)
Lin-Zhi International Inc: 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
- Recall number
- Z-1270-2014
- Recalling firm
- Lin-Zhi International Inc
- 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 Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
- Status
- Terminated
- Initiated
- 2014-02-18
- Posted
- 2014-03-21
- Terminated
- 2014-04-25
- Reason
- 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).
- Root cause
- Packaging
- Action
- Lin-Zhi International sent a Recall letter dated February 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters acknowledge that Lin Zhi was notified by the customer that the product could not be qualified and that this was confirmed by Lin-Zhi internal testing. Letters request that the distributor notify all customers of the situation and ask them to destroy any remaining product from the affected lots. the root cause is identified and letters also state that a corrective action has been implemented to prevent future problems. Questions may be directed to Lin Zhi International at 408-732-3856.
- Quantity
- 120 units, 60 of each lot number
- Distribution
- US Distribution including CA.
- Lot, serial or model codes
- Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
- 510(k) numbers
- ["K081008"]
- PMA numbers
- not on file
- Product code
- DJG
- Firm FEI
- 3003610499
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28