Biotestcell I8, Biotestcell I11 and Biotestcell I11E 의 안전성 경고

Safety alert

2014-06-20

2014-06-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140620a.html

Medical device safety alert: bio-rad biotestcell i8, biotestcell i11 and biotestcell i11e medical device manufacturer, bio-rad, has issued a field safety notice (fsn) concerning biotestcell i8 (code no. 816 020), biotestcell i11 (code no. 816 021) and biotestcell i11e (code no. 816 051). the affected lot number is 2422011-00. due to subsequent exchange of one donor cell in the cell panel of the products mentioned above, an incorrect version of the worksheet was used for packaging. this worksheet contains incorrect information for cell i7. with this incorrect worksheet an identification of anti-jkb, -s and -s antibodies is not possible. misinterpretations do not occur. using the affected reagents as control reagent will lead to a discrepant result misleadingly indicating a problem with the tested reagent (e.G. seraclone anti-jkb, anti-s, anti-s). the manufacturer advises users not to use worksheets included in the packages of the lots mentioned above. a fsn with corrected worksheets containing correct donor information for cell i7 was issued to alert users. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 jun 2014.