VITROS Immunodiagnostic Calibrators Recalled for Potential Accuracy Bias
Ortho-Clinical Diagnostics is recalling VITROS Anti HBs Calibrators due to potential for positively biased results caused by signal reduction over shelf life. Approximately 481 units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with no reported illnesses. The potential for biased diagnostic results due to shelf-life signal reduction represents a risk-of-harm product without yet-reported injury, matching rubric criteria for High severity.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Anti HBs Calibrators due to a potential for positively biased results caused by signal reduction over shelf life. This issue could affect the accuracy of diagnostic test results when using affected calibrators.
The recalled product consists of a calibrator pack containing three labeled calibrator tubes (C1 green, C2 yellow, and C3 red). Approximately 481 units were distributed worldwide, including nationwide distribution across the United States and to Bermuda, Colombia, and Singapore.
The affected lots are Lot 9010 (manufactured October 13, 2023; expired July 15, 2024) and Lot 9030 (manufactured December 9, 2023; expired August 26, 2024). These calibrators are used with VITROS Immunodiagnostic testing equipment.
The recalled product
- Product
- VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 481
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 (5)
- Model No. 6801926
- GTIN# 10758750001699
- Lot 9010 (Manufactured 13-Oct-2023
- Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023
- Expiry 26-Aug-2024).
Distribution
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