FDA Medical Device Recalls (openFDA)
Ortho Clinical Diagnostics: VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
- Recall number
- Z-2482-2020
- Recalling firm
- Ortho Clinical Diagnostics
- Product
- VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
- Status
- Terminated
- Initiated
- 2020-05-20
- Posted
- not on file
- Terminated
- 2022-11-16
- Reason
- Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
- Root cause
- Under Investigation by firm
- Action
- Ortho Clinical Diagnostics issued on 20 May 2020, Customer letter (Ref. CL2020-126) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS 3600, 5600 and XT7600 . Letter states reason for recall, health risk, and action to take: In the meantime, manually adding the values in both the serum screen AND the plasma screen (even though the plasma screen appears to be updated already) will prevent the issue by correctly marking the edits to both body fluids with M1. To manually enter these values for Plasma in Options & Configurations: navigate to Plasma, select the assay, select Review/Edit Configuration, edit Qualitative fields to match Serum. If it appears they currently match, retype at least one of the changes, then touch Save. Once the Qualitative Range values have been updated, load an ADD using Retain Configuration. Verify that both Serum and Plasma values match the intended modifications. This indicates that the modifications were marked with a M1 code and will continue to be retained when that option is used during future ADD loads. " A review of previously reported patient results is recommended if you identify an assay modification in which Serum and Plasma do not match. Review Plasma sample results for these assays versus your intended thresholds. Note: if your VITROS System is connected via e-connectivity, the Ortho Care Technical Solutions Center can assist you with obtaining your patient results from the past 90 days. " If you believe this software anomaly has affected sample results in your laboratory, please contact Ortho Care Technical Solutions Center. " Complete the Confirmation of Receipt form Foreign affiliates were informed by email approximately on 20 May 2020 of the issue and instructed to notify their consignees of the issue and required actions until the software mitigation is available. The anomaly will be resolved with software version
- Quantity
- 2617 units (U.S.=1272; OUS=1344)
- Distribution
- US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN
- Lot, serial or model codes
- Affected Serial Number Range : J56000114- J56001879
- 510(k) numbers
- ["K083173"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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