—#147131

Product

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.

FDA product code: LEH — Radioimmunoassay, Vancomycin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K060586
Affected 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)

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Roche sent an Urgent Medical Device Correction letter dated May 26, 2016, to all affected customers via UPS Ground (receipt required) . The letter identified the product the problem and the action needed to be taken by the customer. Customers will be informed to disregard the method comparison data in the package insert and to follow the instructions outlined in UMDC 16-083. Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Affected product under Roche control was placed on hold. Affected product will be reworked to add a sticker referring to customers to UMDC 16-083. Roche is not requesting return of the affected product. Any returned product will be managed according to current procedures. The incorrect method comparison will be removed from the method sheets. Updated method sheets will be released at a later time. Customers may contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

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

Timeline

Recall initiated: 2016-05-26
Posted by FDA: 2016-08-01
Terminated: 2017-03-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.