Roche Recalls Vancomycin Assay Kits Due to Incorrect Method Sheets
Roche Diagnostics is voluntarily recalling Vancomycin assay kits because method sheets contain incorrect comparison data for specific analyzers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text explicitly states it is a voluntary recall due to documentation errors (incorrect method sheets) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay kits. The affected products include the ONLINE TDM Vancomycin 100 tests, ONLINE TDM Vancomycin 200 tests, Hitachi Vancomycin (Modular P), and Hitachi Vancomycin (917, MOD P). These assays are used for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
The recall was initiated because the method sheets provided with these kits state an incorrect method comparison against the COBAS INTEGRA 800 analyzer. This documentation error affects the kits used on the cobas c 311/501/502 analyzers and the Modular Analytics P module.
A total of 53,897 units were distributed nationwide to 49 states and Puerto Rico. The source text does not report any illnesses or injuries associated with this recall. Healthcare facilities and laboratories should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry…
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 53,897
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)
- MOD P)
Distribution
Related recalls
Same manufacturer · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · mis labeling
See all →- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
Similar recalls
- HighRoche Vancomycin Test Recall Due to Inaccurate Low Results
FDA (Devices) · 2019-10-16
- HighRoche Online TDM Vancomycin Gen.3 Recalled for Inaccurate Low Sample Results
FDA (Devices) · 2019-10-16
- ModerateRoche Acetaminophen Assay Method Sheets Missing Interference Statement
FDA (Devices) · 2018-05-02
- HighRoche Recalls Automated Analyzers Due to Possible Sample Mismatch
FDA (Devices) · 2018-01-24
- HighRoche Recalls cobas 4800 HPV Test Kits Due to Formulation Error
FDA (Devices) · 2013-09-18
- HighRoche Homocysteine Test Recalled for Calibration Failures and Quality Control Issues
FDA (Devices) · 2019-12-25