Z-2304-2016 Class II Terminated
FDA device recall Z-2304-2016 was initiated by Roche Diagnostics Operations, Inc. on May 26, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 23, 2017). Affected quantity: 53,897 Units distributed.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 10, 2016
- Initiation Date
- May 26, 2016
- Termination Date
- Mar 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2304-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026