Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results
Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.
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: The recall is classified as FDA Class II and involves a risk of inaccurate diagnostic results (biased results) which could lead to incorrect clinical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics is extending a previous recall from July 2018 to include additional product codes of the VITROS HBeAg Reagent. The recall involves 3,725 units (100 tests per unit) of the reagent, which is used for the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human serum. The affected products were distributed worldwide, including across the United States and in numerous international markets.
The recall is being issued because biased results may occur for these additional products at biotin concentrations that are lower than indicated in the current Instructions for Use. This potential for bias could affect the accuracy of laboratory diagnosis for individuals with acute or chronic hepatitis B, or those recovering from hepatitis B infection. The recall includes all expired, in-date, and future lots released.
Healthcare facilities and laboratories should stop using the affected VITROS HBeAg Reagent and contact Ortho-Clinical Diagnostics for instructions on how to return the product. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus…
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
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)
- All expired
- in-date
- and future lots released.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by ORTHO-CLINICAL DIAGNOSTICS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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