Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Che

FDA device recall Z-0008-2024 · posted 2023-10-02 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJE

Quantity affected

9,860 assemblies

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2023-08-09

Date posted

2023-10-02

Location

Rochester, NY

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