Alerta De Seguridad para ID-DiaCell I-II-III Asia

Safety alert

2017-09-04

2017-09-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170904.html

Medical device safety alert: bio-rad id-diacell i-ii-iii asia medical device manufacturer, bio-rad, has issued a medical device safety alert concerning its id-diacell i-ii-iii asia. the affected products are identified as follows:- product code: 45330 lot/serial numbers: ihd lot n°: 45330 29 1 (expiry date: 09.10.2017) / sap lot n°: 167516291 (expiry date: 11.09.2017) ihd lot n°: 45330 29 2 (expiry date: 23.10.2017) / sap lot n°: 168117292 (expiry date: 23.10.2017) ifu/um reference: b004350 version 02.15 the manufacturer has been made aware that unexpected positive reactions may occur with the cell iii of the product id-diacell i-ii-iii asia, ihd lot n° 45330 29 1 and 45330 29 2 according to the manufacture’s health risk assessment, there is no patient risk because by following the good laboratory practice practices the issue (false positive reaction) will be identified during internal quality control. the manufacturer requests customers to scrap any remaining goods of the ihd lots 45330 29 1 and 45330 29 2. the manufacturer is sending the lots 45330 30 1 respectively 45330 30 2 as a replacement in week 36. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 4 september 2017.