Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir — Class II medical device recall Z-1028-2013
Terminated recall by Roche Diagnostics Operations, Inc., reported 2013-04-10, distributed nationwide. Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequ
| Recall number | Z-1028-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2013-03-01 |
| Classified | 2013-04-01 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2014-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 189 units |
| Lot numbers | 477415, 477416, 477898, 477899 |
| Model numbers | 05232732001 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1028-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.