ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P);...

FDA Device Recall #Z-2304-2016 — Class II — May 26, 2016

Recall Summary

Recall Number Z-2304-2016
Classification Class II — Moderate risk
Date Initiated May 26, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Roche Diagnostics Operations, Inc.
Location Indianapolis, IN
Product Type Devices
Quantity 53,897 Units distributed

Product Description

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 analyzers.

Reason for Recall

Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.

Distribution Pattern

Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN,TX, UT, VA, VT, WA, WI, WV, WY Foreign:None VA/DOD: See list below

Lot / Code Information

04491050190  ONLINE TDM Vancomycin 100 tests 05108420190  ONLINE TDM Vancomycin 200 tests 04642490190  Hitachi Vancomycin (Modular P) 04642481190  Hitachi Vancomycin (917, MOD P)

Other Recalls from Roche Diagnostics Operations, Inc.

Recall # Classification Product Date
Z-1476-2026 Class II cobas pro integrated solutions with cobas c 503... Jan 20, 2026
Z-1009-2026 Class II The Elecsys Anti-TSHR immunoassay is a three-st... Nov 21, 2025
Z-0489-2025 Class II cobas HCYS, Homocysteine Enzymatic Assay, Mater... Oct 17, 2024
Z-3187-2024 Class II Creatine Kinase (CK) used on cobas c 311/501/50... Aug 15, 2024
Z-0352-2024 Class II Tina-quant D-Dimer Test System, Fibrinogen/Fibr... Oct 3, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.