Z-0290-2018 Class II Terminated
FDA device recall Z-0290-2018 was initiated by Remel Inc on December 8, 2017 and is designated Class II. Reason for recall: The serum may fail to agglutinate within the specified minimum reaction time. The recall status is terminated (terminated July 22, 2020). Affected quantity: 237 units (single bottles).
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2018
- Initiation Date
- December 8, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237 units (single bottles)
Product Description
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 for Recall
The serum may fail to agglutinate within the specified minimum reaction time.
Distribution Pattern
US Nationwide Distribution
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.