VITROS Immunodiagnostic Products 25-OH Vitamin D Total recall
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators…
Why was VITROS Immunodiagnostic Products 25-OH Vitamin D Total recalled?
Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
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?
0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110
- Product
- VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 1554 units domestically
- Distribution
- Nationwide
- Recall date
- March 19, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)