Quality Control Tool Vitamin B12 Range Verifier Recalled by FDA
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.
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: FDA Class III designation with no reported patient harm or illness. This is a quality control product failure that is detectable during normal use, resulting in potential operational delays rather than direct patient safety impact. The underlying assay performance is not affected.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot 1200 (UDI-DI: 10758750000937, Expiration Date: September 30, 2024), a laboratory quality control product used to verify the calibration range of VITROS immunodiagnostic systems. A total of 76 units have been distributed worldwide, including throughout the United States and Colombia.
The Range Verifier in Lot 1200 may fail to meet the required range specifications when used to verify calibration at RV Level 2. This failure is detectable by users when the product is processed during normal quality control operations. If this occurs, users may need to switch to an alternate method for range verification.
According to the FDA, this issue does not affect the actual performance of the Vitamin B12 assay on patient samples. Previously reported patient test results are not affected by this product issue, and no review of reported results is required. The FDA notes that any actual assay performance issues would be detected by Quality Control systems.
Healthcare laboratories using this product should check for Lot 1200 and be prepared to use alternate verification methods if the product fails to meet required specifications during processing. For assistance, contact Ortho-Clinical Diagnostics, Inc.
The recalled product
- Product
- VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of v
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- Affected units
- 76
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 (1)
- UDI-DI: 10758750000937 Lot Number: 1200 Exp. Date: 30-Sep-2024
Distribution
Distributed nationwide across the United States.
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