FDA Medical Device Recalls (openFDA)
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 number
- Z-1367-2022
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2022-05-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
- Root cause
- Incorrect or no expiration date
- 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
- Quantity
- 20858
- Distribution
- Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
- Lot, serial or model codes
- UDI-DI :10758750034413. All expired, in-date and future released lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKO
- 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