Recall Z-2038-2023— Remel, Inc

Name: FDA recall Z-2038-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-31

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2023-05-31. It names one FDA 510(k) clearance: K892928. Product: Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.. Reason: The test medium may not perform as intended..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-05-31
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 (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.

Reason for recall

The test medium may not perform as intended.

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