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.
Check against the official notice below — it lists the full affected range.
Remel Inc is recalling Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum (Reference R30164201 ZH01) distributed nationwide in the United States. The product is used in slide agglutination tests to identify Shigella cultures. A total of 237 single bottles across ten specific kit and bottle lot combinations have been recalled because the serum may fail to agglutinate within the specified minimum reaction time, which could affect test results.
The recall affects bottles with kit lot numbers 1465529, 2118879, 2173683, 2161363, 1984639, 1738564, 1971308, 1957305, 1947930, and 1847285 paired with their corresponding bottle lot numbers. The product record does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The serum may fail to agglutinate within the specified minimum reaction time.
Reason for recall: The serum may fail to agglutinate within the specified minimum reaction time. Distribution: US Nationwide Distribution Quantity: 237 units (single bottles) Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.