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
FDA Recall Z-1367-2022 · Posted None
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Recalling FirmOrtho-Clinical Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeQKO
Date Initiated2022-05-26
Product Quantity20858
Reason for Recall
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Firm Action
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
Root Cause
Incorrect or no expiration date
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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