RecallRadar

FDA Device recall Z-1424-2021

Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualit…

On 2021-04-21 the FDA classified a Class II recall of Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualit… by Remel, citing when tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1424-2021
ClassificationClass II
Statusongoing
Initiated2021-03-10
Published2021-04-21
Last updated2026-09-13 11:56 UTC
CompanyRemel
DistributionUS

Product

Remel 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.

Reason

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

Identifiers

code_infoLot Numbers: 201334 Exp. 2021-01-21, 210892 Exp. 2021-02-03, 217048 Exp. 2021-02-10

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1424-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.