Reported Jan 3, 2018 · Terminated

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

Remel Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519

Is this the product you have?

  • Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01
  • Product UsageSuitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes
Lot codes and dates

10 of 10 products

Products covered by this recall
#BarcodesProduct as published
150560805009592UDI 50560805009592. Kit lot #1465529, Bottle lot #1465528
2Kit lot #2118879, Bottle lot #1847290
3Kit lot #2173683, Bottle lot #1847290
4Kit lot #2161363, Bottle lot #1847290
5Kit lot #1984639, Bottle lot #1847290
6Kit lot #1738564, Bottle lot#1738565
7Kit lot #1971308, Bottle lot #1738565
8Kit lot #1957305, Bottle lot #1738565
9Kit lot #1947930, Bottle lot #1738565
10and Kit lot #1847285, Bottle lot #1738565.
Amount recalled
237 units (single bottles)

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 22, 2020 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.