Ortho VITROS URIC Slides Recalled Due to NAC Interference
Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay 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: The recall is classified as FDA Class II, but the hazard is an analytical interference (NAC) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity involving potential diagnostic errors without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products URIC Slides (REF/Product Code 194 3927) because the company confirmed that N-Acetylcysteine (NAC) can interfere with the assay. NAC is a drug used for acetaminophen overdose, mucolytic therapy, and as a nutritional supplement.
The recall affects sales units distributed worldwide, including the United States, Puerto Rico, Bermuda, and various international markets. The affected product lots are identified by Generation numbers 26, 27, 28, 29, and 31.
Healthcare providers and laboratories should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions regarding the recall and potential replacement.
The recalled product
- Product
- VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
- 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 (5)
- Current/In-date GENs 26
- 27
- 28
- 29
- 31
Distribution
Part of a larger recall action
This product is one of 4 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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