Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack 의 리콜

Recall

74828

Class 3

Z-2580-2016

2016-07-28

Terminated

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148548

A field correction was issued by the firm for vitros tsh reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. customers using vitros tsh lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for vitros tsh.

Ortho Clinical Diagnostics sent an Important Product Correction Notification letter on July 28, 2016, via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS Immunodiagnostic Product TSH, Lot 5040 to inform them of the issue and the required actions. Instructions were provided to customers. Customers with questions were instructed to contact Ortho Care" Technical Solutions Center at 1-800-421-3311. Foreign affiliates were informed by e-mail on July 28, 2016, of the issue and instructed to notify their consignees of the issue and the required actions. For questions regarding this recall call 908-218-8776.