Class 1 Device Recall Thermo Scientific Sensititre HPB1

• Date Initiated by Firm: October 20, 2022
• Date Posted: December 08, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0330-2023
• Recall Event ID: 91104
• 510(K)Number: K860753 K936305 K880641 K073424 K060621 K983244
• Product Classification: Gram negative identification panel - Product Code JWY
• Product: Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
• Code Information: Lot Numbers: B2206A, B2035A, B1333, B1144A, B0483
• Recalling Firm/ Manufacturer: Remel Inc; 12076 Santa Fe Trail Dr; Lenexa KS 66215-3519
• For Additional Information Contact: Tom Campbell; 913-895-4077
• Manufacturer Reason for Recall: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm issued an "Urgent Medical Device Correction" notice to its consignees on 10/25/2022 by US mail. The notice explained the issue, risk to health, and notified the consignees of an update to the IFU, specifically, "to add limitations for Carbapenems (Imipenem, Doripenem, Meropenem, Ertapenem), Cefepime, Piperacillin/Tazobactam and Aztreonam added for users to "NOT REPORT" any result for each member of the Protea tribe (including Proteus spp., Providencia spp., Morganella Morganii) to address false susceptible results." Please complete and return the Required Customer Reply form via email to MBD.vigilance@thermofisher.com. Please keep this notification on file. The notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. This correction notification is being made and performed by the US agent, Remel Inc., on behalf of the Foreign Manufacturer of the affected product, Trek Diagnostic Systems Ltd., located in East Grinstead, UK. Trek Diagnostic Systems and Remel Inc., both part of Thermo Fisher Scientific, are investigating the root cause and will implement corrective actions to prevent future recurrence. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
• Quantity in Commerce: 665 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JWY and Original Applicant = GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.; 510(K)s with Product Code = JWY and Original Applicant = RADIOMETER AMERICA, INC.; 510(K)s with Product Code = JWY and Original Applicant = SENSITITRE LTD.; 510(K)s with Product Code = JWY and Original Applicant = TDS HOLDINGS INC.; 510(K)s with Product Code = JWY and Original Applicant = TREK DIAGNOSTIC SYSTEMS, INC.