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Lower risk Medical device recall · FDA · Published March 10, 2021

Remel Haemophilus Test Medium: Light Growth Zones May Affect Test Accuracy

Remel recalls Haemophilus Test Medium (10/PK) due to potential light growth zones causing measurement errors in antimicrobial tests. Affected lots expire Feb 2021.

🇺🇸 FDA recall #Z-1425-2021Medical deviceRemel ›
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Recalling firmRemel Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519
✎ GovInfoNow plain-language explainer

Remel is recalling Haemophilus Test Medium (100mm) 10/pack because it may show lighter growth patterns when testing with certain bacteria, making it hard to measure antibiotic zones accurately. This could lead to incorrect test results in lab settings. Read more at govinfonow.com/recall/63107-remel-haemophilus-test-medium-light-growth-zones-may-affect-test.

Source Summary by GovInfoNow · govinfonow.com/recall/63107-remel-haemophilus-test-medium-light-growth-zones-may-affect-test · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1425-2021

Cite this page

“Remel Haemophilus Test Medium: Light Growth Zones May Affect Test Accuracy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63107-remel-haemophilus-test-medium-light-growth-zones-may-affect-test. Based on FDA recall #Z-1425-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1425-2021%22&limit=1).

The FDA announced on March 10, 2021, that Remel Inc. is recalling Remel Haemophilus Test Medium (100mm) 10/PK due to potential growth issues. The hazard involves lighter than normal growth of specific organisms, making zones difficult to measure.

How to tell if you have it

  • Brand: Remel
  • Product: Remel Haemophilus Test Medium(100mm) 10/PK
  • REF: R01503
  • Lot Number: 220711
  • Expiration Date: 2021-2-17
  • Quantity: 19 units

The hazard

When tested with H. influenza ATCC 49247 and ATCC 49766, both organisms may exhibit lighter than normal growth making zones difficult to measure.

Context

GovInfoNow's records show Remel, Inc has 22 other recalls on record since 2017-11-02. Other recent recalls of similar products include Remel GC Agar Base Recall (2026-06-03), Remel Yeastone Broth Recall (2026-03-24), and Remel Campy CVA Medium 100/PK recall (2026-02-05). Additional similar product recalls include Remel Neisseria meningitidis Gp C 2ml/VL recall (2026-07-17) and Remel Oxoid Agglutinating Sera Recall (2026-03-25).

How to tell if you have this one

Check for lot numbers on the packaging, such as Lot 220711. The product expires February 17, 2021, and is sold as a 100mm solid medium in packs of 10.

  • Brand
    Remel
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1424-2021Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.; Lot Numbers: 201334 Exp. 2021-01-21, 210892 Exp. 2021-02-03, 217048 Exp. 2021-02-10408 units
Z-1425-2021Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.; Lot Numbers: Lot 220711 Exp. 2021-2-1719 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for the lot number on the packaging, such as Lot 220711.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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 published this recall 42 days after the firm started it.

1. Firm started the recall: Mar 10, 202112. FDA classified it Class II: Apr 13, 202123. Published in FDA’s Enforcement Report: Apr 21, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1425-2021 (March 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1425-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA