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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
Related recalls
Same manufacturer · Remel, Inc
See all →- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- HighYeastone Broth recalled because it may report incorrect susceptibility results
FDA (Devices) · 2026-04-22
- SevereRemel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery
FDA (Devices) · 2026-03-04
- ModerateCulture media recalled over contamination that may darken the broth
FDA (Devices) · 2025-12-03
- HighStrep Selective II Agar plates may carry Listeria monocytogenes contamination
FDA (Devices) · 2025-08-06
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateRemel Haemophilus Test Medium Recalled for Poor Organism Growth
FDA (Devices) · 2017-03-15
- ModerateRemel Haemophilus Test Medium Recalled Due to Growth Issues
FDA (Devices) · 2021-04-21
- ModerateRemel Haemophilus Test Medium Recalled for Reduced Organism Growth
FDA (Devices) · 2021-04-21
- ModerateRemel Blood Agar Bi-Plate Recalled for Poor Microbial Growth
FDA (Devices) · 2021-01-20
- ModerateRemel Thioglycollate Medium Recalled for Performance Testing Failures
FDA (Devices) · 2018-09-19
- HighRemel Blood Agar Plates Recalled for Listeria Contamination
FDA (Devices) · 2017-05-03