Recall Z-1947-2025— Remel, Inc

Name: FDA recall Z-1947-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-01

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2025-05-01. It names one FDA 510(k) clearance: K111429. Product: Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device. Reason: Product may have an off color affecting perfomance.

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-05-01
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K111429 — SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...Trek Diagnostic Systems, Ltd.·cleared 2011-08-18

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

Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

Reason for recall

Product may have an off color affecting perfomance

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