Class II — Roche Diagnostics Operations, Inc.
| Recalling firm | Roche Diagnostics Operations Inc. |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent. |
| Product | Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas® CT/NG 4800 System, for in vitro diagnostics. |
| Quantity | 189 units |
| Distribution | Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM. |
| Initiated | 2013-03-01 |
| Classified | 2013-04-01 |
| Terminated | 2014-06-04 |
| Recall number | Z-1028-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Roche Diagnostics Operations, Inc. (Z-1028-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64453/
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