vitros immunodiagnostic products tsh calibrators; vitros immunodiagnostic products tsh reagent packs 의 안전성 경고

Safety alert

2014-07-17

2014-07-17

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140717a.html

Medical device safety alert: ortho clinical diagnostics vitros immunodiagnostic products tsh calibrators; vitros immunodiagnostic products tsh reagent packs medical device manufacturer, ortho clinical diagnostics, has issued a field safety notice concerning vitros immunodiagnostic products tsh calibrators (with product code 1487289) and vitros immunodiagnostic products tsh reagent packs (with product code 1912997). the affected products have a lot number of 4540 and an expiry date of 11 feb 2015. the manufacturer received complaints from some customers who were unable to generate a successful calibration using vitros tsh calibrators and reagent packs, lot 4540 on vitros 5600 and 3600 systems. the manufacturer has received no complaints of failed calibrations on the vitros eci/eciq system. furthermore, the manufacturer has confirmed that vitros tsh calibrators and reagent packs, lot 4540 may generate lower than expected calibrator level 1 signals on some vitros 5600 and vitros 3600 systems, resulting in a failed calibration due to an elevation in the ratio of signals for calibrator levels 1 and 2 (delta1). if the laboratory has a vitros eci/eciq system, users may continue to use vitros tsh calibrators and reagent packs, lot 4540 on the vitros eci/eciq system. any remaining inventory of lot 4540 is recommended to be used on the vitros eci/eciq system only. if the laboratory has a vitros 5600 and/or a vitros 3600 only: - users who have successfully calibrated vitros tsh calibrators and reagent packs, lot 4540 may continue using the current inventory until they have received the new product, provided that the tsh quality control results are acceptable. - to avoid experiencing this issue in the future, users should discontinue using and discard all vitros tsh calibrators and reagent packs, lot 4540 after receiving the new product. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 jul 2014.