FDA Medical Device Recalls (openFDA)
Lin-Zhi International Inc: 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, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
- Recall number
- Z-0386-2014
- Recalling firm
- Lin-Zhi International Inc
- 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, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
- Status
- Terminated
- Initiated
- 2013-10-03
- Posted
- 2013-11-25
- Terminated
- 2013-12-26
- Reason
- Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.
- Root cause
- Under Investigation by firm
- Action
- Beckman Coulter sent a Manufacturer Field Action Letter dated November 2013, to the one distributor. The letter identified the product the problem and the action needed to be taken by the customer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. If you have any questions regarding this notice, please contact our Customer Support Center Via our website, http://www.beckmancoulter.com/customersupport/support Via phone, call 1-800-854-3633 in the United States Outside the United States, contact your local Beckman Coulter Representative. We apologize for any inconvenience.
- Quantity
- 60 items
- Distribution
- US Distribution in CA.
- Lot, serial or model codes
- Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
- 510(k) numbers
- ["K081008"]
- PMA numbers
- not on file
- Product code
- LAS
- 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