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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 4

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  Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 4 see related information
Date Initiated by Firm February 18, 2021
Create Date March 23, 2021
Recall Status1 Terminated 3 on October 18, 2022
Recall Number Z-1295-2021
Recall Event ID 87390
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
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
Code Information Lot Numbers: 0449 (exp. 28-Aug-2021) 0459 (exp. 10-Feb-2022) 0460 (exp. 01-Oct-2022) UDI: (10758750008537)
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer 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).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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