FDA Device recall Z-0290-2018
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01
- FDA Device
- Class II
- terminated
- Published 2018-01-03
On 2018-01-03 the FDA classified a Class II recall of Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01 by Remel, citing the serum may fail to agglutinate within the specified minimum reaction time.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0290-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-08 |
| Published | 2018-01-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Remel |
| Distribution | US |
Product
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
Reason
The serum may fail to agglutinate within the specified minimum reaction time.
Identifiers
| code_info | UDI 50560805009592. Kit lot #1465529, Bottle lot #1465528; Kit lot #2118879, Bottle lot #1847290; Kit lot #2173683, Bo…UDI 50560805009592. Kit lot #1465529, Bottle lot #1465528; Kit lot #2118879, Bottle lot #1847290; Kit lot #2173683, Bottle lot #1847290; Kit lot #2161363, Bottle lot #1847290; Kit lot #1984639, Bottle lot #1847290; Kit lot #1738564, Bottle lot#1738565; Kit lot #1971308, Bottle lot #1738565; Kit lot #1957305, Bottle lot #1738565; Kit lot #1947930, Bottle lot #1738565; and Kit lot #1847285, Bottle lot #1738565. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2018%22
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