Urgent Field Safety Notice

Transcription

1 Urgent Field Safety Notice October 2016 Product Name: Syphilis 100 Product Name: Syphilis 100 (+ Product Name: Syphilis 500 Product Name: 1 Antigen 100 ml Product Name: 1 Antigen 5 ml Product Name: RPR Carbon Cards 8H H60070A 8H H60071A 8H60071B 8H H / Type of action: Device Destruction Dear Valued Customer, The products are non-trepanemal tests for the qualitative and semi-quantitative detection of Syphilis using serum (heated or unheated) or plasma. Our records indicate that you may have purchased at least one of the above products and we would like to share the following important information with you. Problem Statement Through our investigations we have determined that there is a potential sensitivity performance issue with the products, as detailed above. Our investigation has shown that the lots detailed in Tables 1-8 are impacted by this issue. Kits/components from these lots must be destroyed. Table 1: Syphilis Product Lots to be destroyed F May-17 8H60070 Syphilis 100 F ct-17 Table 2: Syphilis 100 (+ - Product Lotstobe destroyed D ct-16 D ct-16 Syphilis 100 (+ 8H60070A F May-17 D ct-17 Table 3: Syphilis 500- Product Lotto be destroyed Syphilis 500 8H60071 F Feb-17 T Trin ity Biotech Manufacturing Limited Bray, Co Wieklew in fo@t rinitybiotech.com rinitybiotech.com Registered in l reland. Reglstration number Directors : Dr. J Walsh. Kevin Tansley.

2 Table 4: Syphilis 500 (+ - Product Lotstobe destroyed D Feb-17 Syphilis 500 (+ 8H60071A F Feb-17 Table 5: Syphilis 500 (+ - Product Lotstobe destroyed D Jan-17 D Jan-17 D Jun-17 Syphilis 500 (+ 8H60071B F Mar-18 F F Table 6: 1 Antigen 100 ml - Product Lots to be destroyed D Feb-17 1 D May-17 8H52215 Antigen 100 ml F ct-17 F Table 7: 1 Antigen 5 ml - Product Lots to be destroyed D Feb-17 D May H52216 D May-17 Antigen 5 ml F F Table 8 RPR Carbon Cards- Product Lots to be destroyed Component Product code Kit Iot Number Expiry Date GRN N/A RPR Carbon 23805/23040 GRN N/A Cards GRN N/A Risk to Health lnvestigation testing has shown that the impacted kit/component lots detailed in Tables 1-8 may fail to detect weak positive samples. Trinlty Blotech Manufacturing Umited On e Southern Cross!DA Busi ness Pa rk Bray, Co Wi cklow info@trinitybiotech.com Registered in lreiand. Reglstration number

3 Actions required Due to our investigation findings, customers and end-users are asked to comply with the following actions with immediate effect: Discontinue the use ofthe lots in Tables 1-8. Destroy any remaining product. in line with your own laboratory's internal procedures, consider the need to review results previously generated using these lots. Notify all end-users of this notification. Complete the attached Faxback form. in addition and as an additional precaution, end-users should assess the need to review results previously generated using expired lots. A thorough investigation into the root cause has been initiated and any corrective/preventive actions will be implemented as appropriate. is committed to affering quality products and superior customer service. wishes to sincerely apologise for the inconvenience caused as a result of this Urgent Field Safety Notice. if you have any questions or comments arising from this Urgent Field Safety Notice, please contact: Post: Telephone: Fax: (address below) , ask for infectious Disease Technical Support Team infectiousdisease.techsupport@trinitybiotech.com Regards, i nfo@trin itybiotech.com w w w.t rin it yblotech.com Trinlty Biolech Manufacturing Llm ited Reglstered in I rela nd. Registration number

4 Urgent Field Safety Notice - FAXBACK FORM 21st October 2016 Piease complete and promptly return (by or Fax) to: Yvonne Kenny, Regulatory Affairs Department, vvonne.kenny@trinitybiotech.com or Fax: Product Name: Syphilis 100 Product Name: Syphilis 100 (+ Product Name: Syphilis SOO Product Name: Syphilis 500 (+ pipst irs) Product Name: 1 Antigen 100 ml Product Name: 1 Antigen 5 ml Product Name: RPR Ca rbon Cards Product Cod e: 8H60070 Product Cod e: 8H60070A 8H60071 Product Cod e: 8H60071A Product Cod e: 8H60071B Product Code : 8H Product Cod e: 8H52216 Product Cod e: 23805/ Type of action : Customer Name: Customer Address: Dear <Name> Device Destruction Our records indicate you have received kits of one or more of the above mentioned lots. Further to the enclosed Urgent Fi eld Safety Notice, you are requested to complete the following: Customers are instructed to discontinue use of the Tables 1-8 Lot(s) immediately and dispose of any remaining inventory. Product Name/ Product Product Name/ Product Product Name/ Product Name/ Code Code Product Code Product Code MicroTrak" RPR Syphilis MicroTrak" RPR Syphilis 100 MicroTrak" RPR Syphilis MicroTrak" RPR Syphilis /8H60070 (+ / 8H60070A 500/8H60071 (+ / 8H60071A Lot # of ki ts Lot # of kits Lot # of kits Lot # of kits Number( s) destroyed Number(s) destroyed Number( s) destroyed Number(s) destroyed lmpacted lmpacted lmpacted lmpacted Product Name/ Product Product Name/ Product Product Name/ Product Name/ Code Code Product Code Product Code MicroTrak" RPR Syphilis 500 MicroTrak" RPR 1 Antigen MicroTrak" RPR 1 Antigen 5 RPR Carbon (+ / 8H60071B 100 ml/ 8H52215 ml/ 8H52216 Cards/23805/23040 Lot # of kits Lot # of kits Lot Lot Lot # of cards Number( s) destroyed Number( s) destroyed Number( s) Number(s) Number(s) destroyed lmpa cted lmpacted lmpacted lmpacted lmpacted Note: Print additional copies if required. Disposed by: Date: _ On e Southern Cross info@ trinitybiotech. com Manufacturing Llmlted Registered in. Reglstration number

5 I have notified my customers of this Urgent Field Safety Notice Number of cu stomers notified: V es No Printed Name: Title: Fax: Signed: Date : Phone: Comments:!DA Bu si ness Pa rk info@trin itybiotech. com Trinlty Biotech Manufacturing Limlted Reglstered in I reland. Reglstration number Directors: Dr. J Walsh. Kevin Tansiey.