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
- Company
- Ortho-Clinical Diagnostics, Inc.
- Recall Initiated
- May 26, 2022
- Recall Number
- Z-1367-2022
- Quantity
- 20858
- Firm Location
- Rochester, NY
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).
Distribution
Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Lot / Code Info
UDI-DI :10758750034413. All expired, in-date and future released lots
Root Cause
Incorrect or no expiration date
Action Taken
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