Roche Recalls CoaguChek XS Pro Systems Due to Potential Test Errors
Roche is recalling 537 CoaguChek XS Pro Systems because they may display an error message instead of a prothrombin time value.
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 medical device that may fail to report critical test results (undetected elevated INR), which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 537 CoaguChek XS Pro Systems. The recall involves the CoaguChek XS Pro meter and CoaguChek XS PT Test strips, which are used to quantitatively determine prothrombin time (PT) using capillary or venous whole blood.
The recall is being conducted because Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, the device may display an ERROR 6 message instead of a numerical value.
The affected units were distributed nationwide. Consumers and healthcare providers should stop using the recalled devices and contact Roche Diagnostics Operations, Inc. for instructions on replacement or refund.
The recalled product
- Product
- CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
- Manufacturer
- Roche Diagnostics Operations, 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 (1)
- Model/Catalog/Part Number: 05530199160
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Roche Diagnostics Operations, Inc. 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 · 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 · test error
See all →- HighBeckman Coulter Analyzer Recalled for Pneumatic Tubing Defects
FDA (Devices) · 2024-09-25
- HighMedical Device Recall: DYNEX Agility Analyzer Control Sample Aspiration Defect
FDA (Devices) · 2022-06-08
- ModerateAbbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues
FDA (Devices) · 2019-04-10
- ModerateBD MAX UVE Specimen Collection Kit Recalled for Test Result Issues
FDA (Devices) · 2018-01-31
- HighBiomerieux Recalls VITEK 2 Gram Negative Test Kits Due to Errors
FDA (Devices) · 2017-08-02
Similar recalls
- SevereRoche CoaguChek XS Prothrombin Time Test Strips Recalled for High INR Results
FDA (Devices) · 2018-11-14
- HighRoche Recalls CoaguChek XS Pro Meters Due to Barcode Reading Errors
FDA (Devices) · 2013-04-24
- HighRoche CoaguChek XS Prof Meters Recalled for Potential Unit Misinterpretation
FDA (Devices) · 2021-01-13
- HighRoche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation
FDA (Devices) · 2021-01-13
- HighInternational Technidyne Recalls Pro Time 3 Cuvettes for Inaccurate PT/INR Results
FDA (Devices) · 2013-02-27
- HighRoche Recalls Accu-Chek Inform II Barcode Scanners Due to Decoding Errors
FDA (Devices) · 2013-04-24