Ortho-Clinical VITROS Chemistry LAC Slides Recalled Due to NAC Interference
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC 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. The hazard involves potential assay interference by a specific drug (NAC), which is a moderate risk to diagnostic accuracy but does not involve direct physical injury or high-risk pathogens.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products LAC Slides, specifically REF/Product Codes 843 3880 and 815 0112. These in vitro diagnostic (IVD) products are used to quantitatively measure lactate (LAC) concentration in plasma using VITROS Chemistry Systems.
The recall was initiated because Ortho-Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy, and as a nutritional supplement, can interfere with the VITROS LAC Slides assays. This interference may affect the accuracy of the lactate measurements.
The affected units were distributed worldwide, including the United States (nationwide, Puerto Rico, and Bermuda) and internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela. The recall covers 32,081 sales units in the US and 29,932 sales units foreign. Users should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products L
- 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 (2)
- Current/In-date GENs 30
- 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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