FDA Medical Device Recalls (openFDA)
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 for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
- Recall number
- Z-2304-2016
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-05-26
- Posted
- 2016-08-01
- Terminated
- 2017-03-23
- Reason
- 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
- Under Investigation by firm
- Action
- 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.
- Quantity
- 53,897 Units distributed
- 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
- Lot, serial or model codes
- 04491050190 ONLINE TDM Vancomycin 100 tests 05108420190 ONLINE TDM Vancomycin 200 tests 04642490190 Hitachi Vancomycin (Modular P) 04642481190 Hitachi Vancomycin (917, MOD P)
- 510(k) numbers
- ["K060586"]
- PMA numbers
- not on file
- Product code
- LEH
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28