Alerte De Sécurité sur Ipsogen Kits

Safety alert

2017-248

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/458174-fda-advisory-no-2017-248

Fda advisory no. 2017-248 voluntary recall of ipsogen bcr-abl1 mbcr is-mmr kit and ipsogen bcr-abl1 mbcr rgq rt-pcr kit all are hereby advised by the food and drug administration (fda) about the lots of the following research use only (ruo) ipsogen kits distributed by getz bros. philippines inc. 5th floor ortigas bldg. ortigas ave pasig city, philippines: research use only (ruo) kit name kit ref kit lot is-mmr calibrator mat is-mmr calibrator lot erroneous ncn assigned is-cal value for the is-mmr calibrator corrected ncn assigned is-cal value for the is-mmr calibrator ipsogen bcr-abl1 mbcr is-mmr kit 670713 95701390 1071927 95701327 0.081 0.124 95701403 95701513 95701655 95701524 95700448 95700957 0.094 0.143 95700450 95700997 95701174 95701664 95701806 0.092 0.140 95701896 95701897 95701974 ipsogen bcr-abl1 mbcr rgq rt-pcr kit 670913 95701191 1062899 95701222 0.1238 0.1848 95701413 95701532 95700425 95700842 0.1385 0.2057 the cited product are being voluntarily recalled by getz bros. philippines inc. because of the report issued by its main manufacturer in other country. according to the report, there is a labelling error in the is-cal value used in the calculation for the conversion of the qualitative results to the international standard on certain lots. this error has led to significant change in the molecular response reporting for is-mmr and rt-pcr kits. for the ipsogen bcr-abl1 mbcr is-mmr kit, the magnitude of error may induce a change from “inconclusive result” to “mmr” status or “no mmr” status to “inconclusive result.” for ipsogen bcr-abl1 mbcr rgq rt-pcr kit the magnitude of error may induce a change from “mr4” to “mr4.5”; “mmr” to “mr4”; and “no mmr” to “mmr.” thus, erroneous data might be obtained from these affected lots. all consumers are advised not to purchase or use the affected product lots. distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-248.Pdf.