Z-1295-2021Class II

VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS...

Name: Z-1295-2021 VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2021-02-18
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-02-18 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS... on 2021-02-18. FDA classified it as Class II and gives the reason as "Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and...". 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-1295-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-18
Posted: 2021-03-23
Terminated: 2022-10-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Ortho Clinical Diagnostics on 18 February 2021 issued Product Correction Notice(Ref. CL2021-054) states reason for correction, health risk and provided the following information: VITROS TIBC results will show a performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26) and above. Specifically, for VITROS TIBC GEN 26 and above, patient and quality control values may shift lower (approximately 80 g/dL across the measuring range) than other available GENS of VITROS Fe Slides (GENs 22-25). To maintain consistent VITROS TIBC GEN to GEN performance, Ortho will be updating the VITROS Calibrator Kit 4 TIBC values for VITROS Fe Slides GENs 22-25 to match VITROS Fe Slides GENs 26 and above. This will allow the TIBC performance for all VITROS Fe Slides GENs to match the reference method performance utilizing the new MgCO3 lot. The performance adjustment for VITROS Fe Slides GENs 22-25 is expected to be implemented in March 2021. At that time, VITROS TIBC GENs 22-25 will become uncalibrated. Ortho will notify customers in advance of this change. After noting that result of VITROS TIBC GEN 26 and above will shift approximately 80 g/dL from current performance, it is acceptable to continue using all VITROS Fe Slides GENs with the VITROS TIBC Kit and VITROS Calibrator Kit 4. " Complete the enclosed Confirmation of Receipt form no later than February 26, 2021 " Please forward this notification if the product was distributed outside of your facility If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 7546 US and 15280 OUS kits
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Product codes and lots: Lot Numbers: 0449 (exp. 28-Aug-2021) 0459 (exp. 10-Feb-2022) 0460 (exp. 01-Oct-2022) UDI: (10758750008537)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1295-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1295-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-23

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)