Ortho VITROS Chemistry GLU Slides Recalled for Potential Assay Interference
Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.
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 specific substances, which is a moderate risk to diagnostic accuracy without reported injuries or fatalities.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides (REF/Product Code 170 7801) because the company confirmed that N-Acetylcysteine (NAC) can interfere with the assays. NAC is a drug used for acetaminophen overdose, mucolytic therapy, and as a nutritional supplement. The recall also covers findings that Dextran 40 and Glutathione may interfere with the slides, which were identified during validation testing for a proposed change.
The affected products are in vitro diagnostic (IVD) slides used to quantitatively measure glucose concentration in serum, plasma, urine, and cerebrospinal fluid. These slides are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. The recall includes current and in-date generation numbers 10, 11, and 20 through 31.
The recall covers 192,459 sales units distributed in the United States (nationwide, Puerto Rico, and Bermuda) and 231,710 sales units distributed internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela. Users should contact Ortho-Clinical Diagnostics for further instructions on handling the affected slides.
The recalled product
- Product
- VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration
- 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 (3)
- Current/In-date GENs 10
- 11
- 20 through 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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