Ortho-Clinical Diagnostics, Inc. Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI :10758750034413. All expired, in-date and future released lots
Products Sold
UDI-DI :10758750034413. All expired, in-date and future released lots
Ortho-Clinical Diagnostics, Inc. is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagno due to On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Recommended Action
Per FDA guidance
Ortho Clinical Diagnostics issued Important Correction Notification letter (CL2022-135) on May 26, 2022. Letter states reason for recall, health risk and action to take: When using VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack, do not store on-analyzer for longer than 6 weeks. " Until a lot update occurs, OAS for VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack will temporarily require manual monitoring and removal of reagent packs from analyzer no longer than 6 weeks after packs have been opened and loaded onto the analyzer. " Complete the enclosed Confirmation of Receipt form no later than June 9, 2022. " Post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System in your laboratory until further notice. " Please forward this notification if VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026