FDA Device recall Z-1028-2013
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001
- FDA Device
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001 by Roche Diagnostics Operations, citing 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 reagen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1028-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-01 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot / SN : 477415,477416, 477898, and 477899 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1028-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.