Device 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.
Z-0290-2018
Product summary
- Firm
- Remel Inc
- Event
- Event 78728
- Status
- Terminated
- Classification
- Class II
- Quantity
- 237 units (single bottles)
- Official record key
device-enforcement:Z-0290-2018
Official wording
Reason: The serum may fail to agglutinate within the specified minimum reaction time.
Code information: 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.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The serum may fail to agglutinate within the specified minimum reaction time.