Device Recall VITROS Chemistry Products CDM PROM 의 리콜

Recall

68840

Class 2

Z-2214-2014

2014-07-15

2014-08-13

Terminated

United States

2018-05-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128837

Inability to calibrate or use vitros nh3 dt slides, gen 59 with vitros chemistry products dt calibrator kit, lot 44 when cdm prom 0168 or 0169 is installed on vitros dt60/dt60 ii chemistry systems.

Ortho Clinical Diagnostics sent an Urgent Product Correction Notification letter dated July 15, 2014,by Federal Express overnight to all affected customers. All US end-user consignees who had been shipped VITROS NH3 DT slides, GEN 59, Product Code 1532589 were informed of the issue. Customers were instructed to: a) use VITROS DT NH3 slides, GEN 59 with Calibration Data Module, Rev. 0168 or 0169 with VITROS DT Calibrator, Lot 42 if available; or b) If VITROS DT Calibrator, lot 42 is not available, the user is instructed to request CDM, Rev. 0170 to be used with VITROS NH3 DT slides, GEN 59 and VITROS DT Calibrator, Lot 44. Customers were instructed to forward this notice if the product was further distributed outside of their facility. OCD has manufactured a new CDM, Rev. 170, containing the necessary data/calibration mathematics for VITROS DT Calibrator, Lot 44 to be used to calibrate VITROS NH3 DT slides, GEN 59. Customers with questions were instructed to call Customers Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.