PlainRecalls
FDA Devices Moderate Class II Ongoing

Remel 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.

Reported: April 21, 2021 Initiated: March 10, 2021 #Z-1425-2021

Product Description

Remel 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.

Reason for Recall

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

Details

Recalling Firm
Remel Inc
Units Affected
19 units
Distribution
US Nationwide distribution.
Location
Lenexa, KS

Frequently Asked Questions

What product was recalled?
Remel 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.. Recalled by Remel Inc. Units affected: 19 units.
Why was this product recalled?
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1425-2021.