Lin-Zhi International Inc: Medical Device Recall in 2014 - (Recall #: Z-1270-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: February 18, 2014

Date Posted: April 2, 2014

Recall Number: Z-1270-2014

Event ID: 67607

Reason for Recall:

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).

Status: Terminated

Product Quantity: 120 units, 60 of each lot number

Code Information:

Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.

Distribution Pattern:

US Distribution including CA.

Voluntary or Mandated:

Voluntary: Firm initiated