FDA Medical Device Recalls (openFDA)
Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
- Recall number
- Z-1226-2020
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Product
- VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
- Status
- Terminated
- Initiated
- 2019-12-16
- Posted
- not on file
- Terminated
- 2020-11-12
- Reason
- Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
- Root cause
- Under Investigation by firm
- Action
- Ortho Clinical Diagnostics (Ortho) 16 December 2019, customer letter (Ref. CL2019-343) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail.Letter states reason for recall , health risk and provided with required actions depending upon whether VITROS Calibrator Kit 32 was available for use. VITROS Calibrator Kit 32 is available for use in the U.S. therefore the required actions in order to process urine samples on VITROS Na+ Slides are to:calibrate. o discontinue using the calibration for urine sodium (only) obtained using an affected VITROS Calibrator Kit 2 lot until either VITROS Na+ Slide GEN 27 is available and/or GEN 26 performance is updated in mid-late January 2020 (refer to Resolution section). Ortho will expedite 1 sales unit of VITROS Calibrator Kit 32, if needed. Request via Confirmation of Receipt form. o Use an alternate urine sodium method until calibration with VITROS Calibrator Kit 32 is complete. o If no alternate urine sodium method is available for use, consult with your medical director to determine if the urine sodium calibration obtained using an affected VITROS Calibrator Kit 2 lot is acceptable for continued use until: Calibration with VITROS Calibrator Kit 32 is complete or VITROS Na+ Slides GEN 26 performance is updated (refer to Resolution section of the communication). VITROS Calibrator Kit 2 is acceptable to use after this occurs or VITROS Na+ Slides GEN 27 or higher is available. VITROS Calibrator Kit 2 will be acceptable to use. Questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
- Quantity
- 39709 units (12734 US and 26975 OUS)
- Distribution
- Nationwide Foreign: Australia Brazil Canada L3R 4G5 Chile China Colombia India Japan Mexico Singapore United Kingdom France Germany Italy Spain Portugal Poland Russia Denmark Norway Sweden Belgium Netherlands
- Lot, serial or model codes
- Lot # /Exp. Date: Lot 277 11-Dec-2019; Lot 288 31-May-2020; Lot 298 12-Nov-2020; Lot 219 15-Jul-2021. UDI: 10758750009503
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIX
- 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