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 8750005
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 used to calibrate VITROS chemistry analyzer systems. The calibrator kit can cause inaccurate total iron-binding capacity (TIBC) test results when used with the newest generation of VITROS Fe Slides (Generation 26 and above). Specifically, TIBC patient values may be approximately 80 micrograms per deciliter lower than expected when these newer slides are used. The affected calibrator kits were distributed worldwide, including throughout the United States and in numerous other countries.
The recall affects 7,546 kits in the United States and 15,280 kits outside the United States. The affected kits have lot numbers 0449, 0459, or 0460. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
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: 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. Quantity: 7546 US and 15280 OUS kits Lot/code info: Lot Numbers: 0449 (exp. 28-Aug-2021) 0459 (exp. 10-Feb-2022) 0460 (exp. 01-Oct-2022) UDI: (10758750008537)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.