Medical Device Calibrator Kit Assigned Extended Incorrect Expiration Date
Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This FDA Class III recall involves an expiration date labeling error. The potential hazard—biased test results if used past true expiration—is theoretical with no reported illnesses or injuries, and the kit currently remains within its use date.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 1,718 units of VITROS Chemistry Products Calibrator Kit 29 (Model/Catalog Number 6802344, Lot 2953) used to calibrate VITROS chemistry analyzer systems. The kit was assigned an extended expiration date of July 24, 2025 during manufacturing, but the correct expiration date is July 24, 2024.
The concern is that if the kit is used after its true expiration date and the customer does not have their Assay Data Disk updated, the chemistry analyzer system may allow use of the expired calibrator. This could result in biased measurement results for total iron-binding capacity (TIBC) tests.
The affected kit has been distributed worldwide, including throughout the United States, Puerto Rico, and internationally to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, the Netherlands, and the United Kingdom.
Affected laboratories and healthcare facilities should verify the true expiration date on Lot 2953 and ensure they do not use the kit after July 24, 2024. If the kit has already been used, verify test results were obtained from unexpired calibration. Customers should ensure their Assay Data Disk is updated to prevent use of expired calibrators.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent…
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 1,718
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)
- (UDI/GTIN# 10758750002672
- Lot Number 2953
- Expiration Date: 24-Jul-2024
Distribution
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