VITROS Chemistry Products GLU DT Slides GEN 56 의 리콜

Recall

36509

Class 2

Z-0151-2007

2006-11-04

Terminated

United States

2012-08-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48778

Positively biased results when using the vitros¿ chemistry products glu dt slides gen 56.

On 9/26/06, the recalling firm notified its foreign affiliate consignees of this 'field correction', and instructed them to inform their customers who received these slides of this issue, provided them with an updated Calibration Data Module and instructed to re-calibrate these slides for continued use. On 9/27/06, all US end-use consignees were informed of this issue via Federal Express overnight letter (dated 9/27/06), and instructing them to re-calibrate these slides for continued use after they have installed the Calibration Data Module. The new CDMs were sent to all customers with VITROS DT 60/DT60 II Chemistry systems starting 9/27/06 concurrent with, but separate, from the correction letters. This includes consignees who purchased their GLU DT slides from distributors. On 9/28/06, all distributors were notified of this 'field correction', providing instructions and 'Questions & Answers' for them, and instructing them to inform their customers who received these slides of this issue. Calibration Data Modules were sent to all customers with VITROS DT 60/DT60 II Chemistry Systems.