Recall Z-1425-2021— Remel Inc

Name: FDA recall Z-1425-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-10

Class II · Ongoing

Class II FDA medical device recall by Remel Inc, initiated 2021-03-10. It names one FDA 510(k) clearance: K892928. Product: 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: When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure..

Recalling firm: Remel Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-03-10
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K892928 — HAEMOPHILUS TEST MEDIUM (AGAR)Remel Co.·cleared 1989-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.