FDA recall Z-0290-2018

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 for recall

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

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-12-08

Report date

2018-01-03

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2018