The Recall Desk
HighFDA (Devices)·Z-2038-2023·Announced 2023-07-05

Remel Haemophilus Test Medium Agar Packages Recalled for Performance Failure

Remel is recalling specific lot numbers of Haemophilus Test Medium (Agar) because the test medium may not perform as intended. This diagnostic device is used in laboratory testing nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a diagnostic test medium that may not perform as intended. The source text does not report illnesses or injuries; the hazard is functional failure in a risk-of-harm product. Per the rubric, absence of reported illness caps severity at High (score 3).

Plain-English summary

Remel, Inc. is recalling specific lot numbers of Remel Haemophilus Test Medium (Agar), an in vitro diagnostic device available in 150mm and 100mm formats packaged in 10-packs. The recall affects 1,296 packages that were distributed nationwide, including Puerto Rico.

The test medium may not perform as intended, which could affect the accuracy of diagnostic test results in laboratory settings.

Laboratories and healthcare facilities that received affected lot numbers should verify their inventory against the recall list. Affected lot numbers and expiration dates are available from the FDA and Remel.

The recalled product

Product
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Manufacturer
Remel, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
1,296

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • REF R04033 lot numbers and expiration dates: Lot 619859 Exp. 2023-03-23
  • Lot 629086 Exp. 2023-03-31
  • Lot 629087 Exp. 2023-03-31
  • Lot 631001 Exp. 2023-04-11
  • Lot 634496 Exp. 2023-04-18
  • Lot 635369 Exp. 2023-04-19
  • Lot 645950 Exp. 2023-05-11
  • Lot 648004 Exp. 2023-05-18
  • Lot 631958 Exp. 2023-04-12
  • Lot 641527 Exp. 2023-05-02
  • Lot 644542 Exp. 2023-05-09
  • and Lot 648125 Exp. 2023-05-16. UDI-DI #00848838001932.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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