FDA Medical Device Recalls (openFDA)
Ortho Clinical Diagnostics Inc: Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
- Recall number
- Z-0844-2019
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Product
- Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
- Status
- Terminated
- Initiated
- 2018-11-29
- Posted
- not on file
- Terminated
- 2024-02-06
- Reason
- A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
- Root cause
- Under Investigation by firm
- Action
- On November 29, 2018, the firm sent a customer letter all affected customers. All consignees were notified of the issue and informed of revised instructions for VITROS Myoglobin Calibrators: - Reconstitute the calibrators using 1.0 mL distilled water, as per current instructions. - Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total) - Discard reconstituted calibrators after 4 hours. - Acknowledge the information contained in this notification by completing and submitting the Confirmation of Receipt form no later than December 14, 2018. - Post this notification by each VITROS System at your facility that processes this assay or with the user documentation. - Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
- Quantity
- 4030
- Distribution
- Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.
- Lot, serial or model codes
- Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)
- 510(k) numbers
- ["K033300"]
- PMA numbers
- not on file
- Product code
- JIS
- Firm FEI
- 2250051
- Firm city
- Raritan
- Firm state
- NJ
- 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