Ortho VITROS FS Calibrator 1 Recalled Due to Calibration Failure
Ortho-Clinical Diagnostics is recalling VITROS FS Calibrator 1, Lot 91461, because it cannot calibrate dLDL reagents when used with specific Assay Data Disk versions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a functional failure (inability to calibrate) rather than a direct safety hazard like contamination or injury.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Calibrator 1, Lot 91461, due to a customer complaint regarding the inability to calibrate VITROS Chemistry Products dLDL Reagent. The issue occurs when the calibrator is used with Assay Data Disk (ADD) Release Versions 5904 through 5910.
The recalled product is an in vitro diagnostic (IVD) calibrator used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS, 4600 Chemistry, and 5600 Integrated Systems. The affected calibrator is required for calibrating specific assays, including dLDL, RF, hsCRP, and others. The recall covers 160 kits in the United States and 642 kits distributed in foreign countries.
Distribution was worldwide, including the United States (nationwide and Puerto Rico) and countries such as Australia, Brazil, Canada, China, Germany, India, Japan, and others. The affected lot has an expiry date of September 19, 2018. Users should stop using the affected calibrator and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 (3)
- Lot 91461
- Expiry Date 2018-09-19
- Affected Assay Data Diskettes (ADD) Release Versions 5904 through 5910
Distribution
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