Z-1295-2021 Class II Terminated
Recalled by Ortho-Clinical Diagnostics, Inc.
— Rochester, NY
FDA device recall Z-1295-2021 was initiated by Ortho-Clinical Diagnostics, Inc. on February 18, 2021 and is designated Class II. 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 v… The recall status is terminated (terminated October 18, 2022). Affected quantity: 7546 US and 15280 OUS kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- February 18, 2021
- Termination Date
- October 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7546 US and 15280 OUS kits
Product Description
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
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).
Distribution Pattern
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.
Code Information
Lot Numbers: 0449 (exp. 28-Aug-2021) 0459 (exp. 10-Feb-2022) 0460 (exp. 01-Oct-2022) UDI: (10758750008537)