Z-1226-2020Class II

VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry...

Name: Z-1226-2020 VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry...
Creator: Ortho Clinical Diagnostics Inc
Published: 2019-12-16
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-12-16 / Terminated / root cause: manufacturing process

FDA source

Ortho Clinical Diagnostics Inc began a recall of 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... on 2019-12-16. FDA classified it as Class II and gives the reason as "Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1226-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-16
Posted: 2020-02-13
Terminated: 2020-11-12
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
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1226-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1226-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13

Product code JIX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)