Recall Z-0722-2022— Remel Inc

Name: FDA recall Z-0722-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-10

Class II · Ongoing

Class II FDA medical device recall by Remel Inc, initiated 2022-01-10. It names one FDA 510(k) clearance: K193538. Product: Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format. Reason: There are lower than expected MICs for some gram negative species..

Recalling firm: Remel Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-01-10
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K193538 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/mlThermo Fisher Scientific·cleared 2020-03-12

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 Gram Negative Susceptibility Testing Plate, IVD format

Reason for recall

There are lower than expected MICs for some gram negative species.

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