Class 2 Device Recall Proboscis/Piston Assembly part number (PN) J55375

• Date Initiated by Firm: August 09, 2023
• Date Posted: October 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0008-2024
• Recall Event ID: 92927
• 510(K)Number: K182063 K081543 K083173 K031924
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
• Code Information: Assemblies with a date code between 040722 - 121922
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Mr. Joe Falvo; 585-453-3452
• Manufacturer Reason for Recall: Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed to pass release testing and were traced to the molded Proboscis part J56639 with date codes from 040722 onward.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT PRODUCT CORRECTION NOTIFICATION dated 8/9/23 was sent to customers. To determine if your laboratory is using an Assembly that was manufactured within the affected date range, check the date code stamped into the barrel of the Assembly. Refer to the example image below to locate the date code on the barrel component of the Assembly. If your laboratory has an Assembly with a date code between 040722 - 121922, the Assembly is considered affected and must be replaced. REQUIRED ACTION " Determine if any of the impacted VITROS Systems in your laboratory are using an affected Proboscis/Piston Assembly by checking the date code stamped into the barrel component. Once a replacement Proboscis/Piston Assembly is received, discard all affected Assemblies within the date range of 040722 - 121922. " Determine if your inventory of VITROS spare parts contains any affected Proboscis/Piston Assemblies by checking the date code stamped into the barrel component. Once a replacement Proboscis/Piston Assembly is received, discard all affected Assemblies within the date range of 040722 - 121922. " Ensure your laboratory is performing the Leak/Hysteresis test during daily maintenance and performing Quality Control to ensure a properly functioning Proboscis/Piston Assembly until a replacement Assembly is available. " Complete the enclosed Confirmation of Receipt form no later than August 17, 2023. Upon receiving your completed Confirmation of Receipt form, QuidelOrtho will credit your account or send a replacement Proboscis/Piston Assembly (Part. No. J55375), if applicable. " Post this notification by each VITROS 5,1 FS/3600/4600/5600/XT 3400/XT 7600 System until this issue is resolved. " Please forward this notification if the affected product was distributed outside your facility. We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
• Quantity in Commerce: 9,860 assemblies
• Distribution: Worldwide - 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 = JJE and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS; 510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.