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Lower risk Medical device recall · FDA · Published May 31, 2023

Remel Haemophilus Test Medium Agar Recall: May Not Perform as Intended

Remel recalls Haemophilus Test Medium Agar products that may not perform as intended for in vitro diagnostics. Check lot numbers and expiration dates listed in the recall notice.

🇺🇸 FDA recall #Z-2038-2023Medical 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 Agar products that may not work properly for lab tests. This could lead to inaccurate results if used in medical diagnostics. Read more at govinfonow.com/recall/57924-remel-haemophilus-test-medium-agar-recall-may-not-perform-as.

Source Summary by GovInfoNow · govinfonow.com/recall/57924-remel-haemophilus-test-medium-agar-recall-may-not-perform-as · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2038-2023

Cite this page

“Remel Haemophilus Test Medium Agar Recall: May Not Perform as Intended.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57924-remel-haemophilus-test-medium-agar-recall-may-not-perform-as. Based on FDA recall #Z-2038-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2038-2023%22&limit=1).

The FDA announced on May 31, 2023, that Remel, Inc. is recalling specific lots of Remel Haemophilus Test Medium (Agar) because the medium may not perform as intended. The recall affects 1,296 packs distributed nationwide.

How to tell if you have it

  • Brand: Remel
  • Product: Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503
  • Lot numbers: 619859, 629086, 629087, 631001, 634496, 635369, 645950, 648004, 651372 (REF R04033); 623548, 631958, 641527, 644542, 648125 (REF 01503)
  • Expiration dates: 2023-03-23 through 2023-05-23
  • Distribution: Nationwide, including Puerto Rico

The hazard

According to the FDA, the test medium may not perform as intended. The recall is classified as Class II.

Context

GovInfoNow's records show Remel, Inc. has 22 other recalls on record since November 2, 2017. Other recent recalls of similar products include the Remel GC Agar Base Recall (June 3, 2026), the Remel Yeastone Broth Recall (March 24, 2026), and the Remel Campy CVA Medium 100/PK recall (February 5, 2026). Additional recent recalls include the Remel Oxoid Agglutinating Sera Recall (March 25, 2026), the Remel Neisseria meningitidis Gp C 2ml/VL recall (July 17, 2026), and the HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (November 18, 2025).

How to tell if you have this one

Check the product packaging for the lot numbers and expiration dates listed: REF R04033 has lots like 619859 (exp. 2023-03-23) and REF R01503 has lots like 623548 (exp. 2023-03-28).

  • Brand
    Remel
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot numbers and expiration dates on the packaging to confirm if your product is affected.

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: yesFLPuerto Rico: yesPR

FDA distribution: “Distribution was made nationwide, including Puerto Rico. There was no foreign or military 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 35 days after the firm started it.

1. Firm started the recall: May 31, 202312. FDA classified it Class II: Jun 29, 202323. Published in FDA’s Enforcement Report: Jul 5, 202332023
  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-2038-2023 (May 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2038-2023 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