Roche COBAS TaqMan MTB Test Definition Files Recalled for False Negative Risk
Roche is recalling COBAS TaqMan MTB Test Definition Files due to an incorrect cutoff value that may cause false negative results for tuberculosis tests.
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 3/5 (High).
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 involves a diagnostic test where a software error could lead to false negative results for a serious infectious disease (tuberculosis). This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as the hazard is a potential diagnostic error rather than a reported injury or death.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the COBAS TaqMan Mycobacteria tuberculosis (MTB) Test Definition Files (TDF) version 3.0 for both CE-IVD and JPN-IVD tests. The recall involves 335 CE-IVD TDFs and 48 JPN-IVD TDFs. These files are used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits.
The recall is due to an incorrect Target Elbow Max cutoff value of 48 in the software files. This error creates the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50. A false negative result could lead to a missed diagnosis of tuberculosis.
The affected products were distributed worldwide, including 22 EU countries and 41 other countries, as well as Japan, Portugal, and Mexico. Healthcare facilities and laboratories using these specific test definition files with the affected software and kits should stop using them and contact Roche for instructions on replacement or return.
The recalled product
- Product
- COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
- Manufacturer
- Roche Molecular Systems, Inc.
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 (5)
- Material Number: CE-IVD: 04803531190 Kit
- 05574455190 TDF
- JPN-IVD: 04653360190 Kit
- 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits
- JPN-IVD: All Kits.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Roche Molecular Systems, Inc.
See all →- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche cobas Influenza Test Recall Due to False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche cobas Flu/COVID assay recalled for false negative influenza results
FDA (Devices) · 2023-02-15
- HighMedical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
FDA (Devices) · 2022-10-26
- ModerateCobas Liat respiratory virus analyzer units recalled for false Influenza B results
FDA (Devices) · 2022-04-06
Same hazard · false negative result
See all →- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
Similar recalls
- HighRoche Recalls Troponin I Immunoassay Kits Due to False Negative Risk
FDA (Devices) · 2021-05-26
- ModerateRoche Recalls cobas 4800 KRAS Mutation Test Kits for Invalid Results
FDA (Devices) · 2015-01-28
- LowOxford Immunotec T-SPOT.TB50 Tuberculosis Test Kits Recalled for Labeling Error
FDA (Devices) · 2020-09-23
- HighRoche Recalls cobas infinity Software Due to Incorrect Validation
FDA (Devices) · 2020-11-25
- HighRoche Recalls cobas EGFR Mutation Test V2 Due to False Negatives
FDA (Devices) · 2016-07-27
- HighRoche Recalls Troponin I STAT Immunoassay Kits Due to False Negative Risk
FDA (Devices) · 2021-05-26