Ortho-Clinical Diagnostics Recalls VITROS Chemistry Calibrator Kit 31
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 31, Lot 3155, because an incorrect value on the Assay Data Disks prevents successful calibration of the HbA1c assay.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences. The issue is a data error preventing calibration, not a direct physical or chemical hazard.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 520 units of the VITROS Chemistry Products Calibrator Kit 31, Lot 3155. This product is used in conjunction with the VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disks (ADD) with Data Release Versions 5873, 5874, 5875, or 5876. The kit is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System, and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.
The recall is due to an incorrect value (data/calibration mathematics) on the Assay Data Disks. This incorrect value will prevent a successful calibration of the assay. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed worldwide, including nationwide in the United States and in various foreign countries. Users of the VITROS systems should check their inventory for Calibrator Kit 31, Lot 3155, and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemis
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 520
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 (1)
- Lot 3155 Product Codes: 6842906 & 6801876
Distribution
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 · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02