Device Recall MultiAnalyte Urine DAU Cutoff Calibrator 의 리콜

Recall

60743

Class 2

Z-0868-2012

2011-08-23

2012-01-25

Terminated

United States

2012-01-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106374

Multi analyte urine dau cutoff calibrator gives a decreased absorbance reading due to a loss of the bzo (oxazepam) analyte from the solution and may cause false positive readings.

The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D; regarding stabilization of this analyte in solution in its calibrators of controls containing BZO. If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.