VITROS Chemistry Products Calibrator Kit 4-(Calibrator recall
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…
Why was VITROS Chemistry Products Calibrator Kit 4-(Calibrator recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 0449 (exp. 28-Aug-2021) 0459 (exp. 10-Feb-2022) 0460 (exp. 01-Oct-2022) UDI: (10758750008537)
- 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…
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 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.
- Recall date
- March 31, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)