Ortho-Clinical Diagnostics, Inc.: 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)

Recall number

Z-0008-2024

Recalling firm

Ortho-Clinical Diagnostics, Inc.

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)

Status

Open, Classified

Initiated

2023-08-09

Posted

2023-10-02

Terminated

not on file

Reason

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.

Root 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

9,860 assemblies

Distribution

Worldwide - US Nationwide distribution.

Lot, serial or model codes

Assemblies with a date code between 040722 - 121922

510(k) numbers

["K031924","K081543","K083173","K182063"]

PMA numbers

not on file

Product code

JJE

Firm FEI

1000136573

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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