Ortho-Clinical Diagnostics Recalls VITROS Vitamin D Calibrators for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS 25-OH Vitamin D Total Calibrators because they may generate negatively biased results. Users must immediately discontinue use of all current lots.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a potential for inaccurate test results rather than a direct physical injury or contamination.
Plain-English summary
Ortho-Clinical Diagnostics has initiated a recall of VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, specifically Lots 0091 through 0235. These calibrators are used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs for the quantitative measurement of total 25-OH Vitamin D in human serum.
The recall was issued because the affected calibrators may generate negatively biased results. This potential inaccuracy could impact the reliability of diagnostic testing performed using these specific lots.
The recall affects 1,554 units distributed nationwide. Users of the VITROS ECi/ECiQ, VITROS 3600, and VITROS 5600 systems are instructed to immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
The recalled product
- Product
- VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Syst
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 1,554
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 0020
- 0030
- 0040
- 0050
- 0060
- 0070
- 0081
- 0090
- 0100
- 0110
Distribution
Distributed nationwide across the United States.
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