Lower risk Medical device recall · FDA · Published December 8, 2017

Remel Shigella Serum May Fail to Agglutinate - Recall

Remel recalls Shigella sonnei Phase 1 & 2 Agglutinating Serum (Ref R30164201 ZH01) due to potential failure to agglutinate within specified time. Affected kits and bottles from specific lots are listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0290-2018Medical device Remel ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmRemel Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519

✎ GovInfoNow plain-language explainer

Remel is recalling Shigella sonnei Phase 1 & 2 Agglutinating Serum (Ref R30164201 ZH01) because it may fail to agglutinate within the required reaction time. This could lead to inaccurate test results for Shigella cultures. Read more at govinfonow.com/recall/72361-remel-shigella-serum-may-fail-to-agglutinate-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/72361-remel-shigella-serum-may-fail-to-agglutinate-recall · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0290-2018

Cite this page

“Remel Shigella Serum May Fail to Agglutinate - Recall.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72361-remel-shigella-serum-may-fail-to-agglutinate-recall. Based on FDA recall #Z-0290-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2018%22&limit=1).

The FDA announced on Dec. 8, 2017, that Remel Inc voluntarily recalled its Shigella sonnei Phase 1 & 2 Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time. The agency classified the recall as Class II.

How to tell if you have it

Brand: Remel
Product: Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01
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
Quantity: 237 units (single bottles)
Distribution: US Nationwide

The hazard

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

Context

GovInfoNow's records show Remel, Inc has had 22 other recalls on record since Nov. 2, 2017. Other recent recalls of similar products include Remel GC Agar Base Recall (June 3, 2026), Remel Yeastone Broth Recall (March 24, 2026), and Remel Campy CVA Medium 100/PK recall (Feb. 5, 2026).

How to tell if you have this one

Check the kit lot numbers and bottle lot numbers on the product. Affected kits include lots 1465529, 2118879, 2173683, 2161363, 1984639, 1738564, 1971308, 1957305, 1947930, and 1847285 with corresponding bottle lots.

Brand
Remel
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lots
Look for the kit lot and bottle lot numbers on the product packaging to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Dec 8, 2017Firm started the recall
Dec 26, 2017FDA classified it Class II
Jan 3, 2018Published in FDA’s Enforcement Report
Jul 22, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72361-remel-shigella-serum-may-fail-to-agglutinate-recall">Remel Shigella Serum May Fail to Agglutinate - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0290-2018 (December 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0290-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.