Remel Inc: Medical Device Recall in 2021 - (Recall #: Z-1425-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: March 10, 2021
Date Posted: April 21, 2021
Recall Number: Z-1425-2021
Event ID: 87495
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.

Status: Ongoing
Product Quantity: 19 units
Code Information:

Lot Numbers: Lot 220711 Exp. 2021-2-17

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated