FDA Device recall Z-1269-2018
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 0…
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 0… by Roche Diagnostics, citing complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1269-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-18 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
Reason
Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
Identifiers
| code_info | None |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1269-2018%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.