Recall Z-2137-2018— Thermo Fisher

Name: FDA recall Z-2137-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-04

Class II · Terminated

Class II FDA medical device recall by Thermo Fisher, initiated 2018-05-04, terminated 2018-12-19. It names one FDA 510(k) clearance: K850291. Product: remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).. Reason: Product may fail performance testing for S aureus ATCC 43300..

Recalling firm: Thermo Fisher
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Terminated: 2018-12-19
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K850291 — MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICSRemel Co.·cleared 1985-05-10

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 SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

Reason for recall

Product may fail performance testing for S aureus ATCC 43300.

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