Remel Inc recalls Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide…

Recall date

December 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0290-2018

FDA classification

Class II

Brand / firm

Remel Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

The serum may fail to agglutinate within the specified minimum reaction time.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.