Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2304-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 26, 2016

Date Posted: August 10, 2016

Recall Number: Z-2304-2016

Event ID: 74312

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.

Status: Terminated

Product Quantity: 53,897 Units distributed

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)

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

Voluntary or Mandated:

Voluntary: Firm initiated