Roche Diagnostics Operations, Inc.: 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

Is my product affected?

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.

• UPC 04491050190
• UPC 05108420190
• UPC 04642490190
• UPC 04642481190

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. has voluntarily recalled the Online TDM Vancomycin assay used on cobas c 311/501/502 analyzers and the Modular Analytics P module. The recall affects approximately 53,897 units that were distributed nationwide across all U.S. states and Puerto Rico. The reason for the recall is that method sheets included with the product contain an incorrect method comparison against the COBAS INTEGRA 800 analyzer. Four specific lot codes are involved: 04491050190 (ONLINE TDM Vancomycin 100 tests), 05108420190 (ONLINE TDM Vancomycin 200 tests), 04642490190 (Hitachi Vancomycin Modular P), and 04642481190 (Hitachi Vancomycin 917, MOD P).

The source document does not specify a remedy or any actions that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 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 Quantity: 53,897 Units distributed Lot/code info: 04491050190  ONLINE TDM Vancomycin 100 tests 05108420190  ONLINE TDM Vancomycin 200 tests 04642490190  Hitachi Vancomycin (Modular P) 04642481190  Hitachi Vancomycin (917, MOD P)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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