FDA recall Z-1424-2021

Remel Inc · Class II · device

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 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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-03-10
Report date
2021-04-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1424-2021