Ortho-Clinical VITROS Chemistry TRIG Slides Recalled Due to NAC Interference
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
What this means for you
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 the hazard involves a risk of harm (incorrect diagnostic results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products TRIG Slides, specifically REF/Product Codes 133 6544 and 832 9930. The recall is due to the confirmation that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy, and as a nutritional supplement, can interfere with the VITROS TRIG Slides assays.
The affected slides are used for in vitro diagnostic purposes to quantitatively measure triglyceride concentration in serum and plasma. These measurements are utilized in the diagnosis and treatment of patients with conditions such as diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or endocrine disorders.
The recall covers 60,372 sales units in the United States and 145,611 sales units distributed internationally. Affected generations include 16, 17, 19, 20, 22, 23, 24, 25, and 27 through 32. Healthcare facilities and laboratories should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products T
- 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 (9)
- Current/In-date GENs 16
- 17
- 19
- 20
- 22
- 23
- 24
- 25
- 27 through 32
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · assay interference
See all →- HighLDL cholesterol assays recalled over triglyceride interference causing biased results
FDA (Devices) · 2026-01-28
- HighBicarbonate reagent recalled over falsely high results from LDH interference
FDA (Devices) · 2025-12-31
- HighUIBC assay does not meet its labeled hemoglobin interference claim
FDA (Devices) · 2025-08-13
- HighEstrone RIA kits give falsely increased results from a bovine albumin lot
FDA (Devices) · 2025-07-30
- ModerateBeckman Coulter Access Unconjugated Estriol Assay Systems Recalled for Interference
FDA (Devices) · 2020-09-30