Recall Z-2599-2018— Beckman Coulter Inc.

Name: FDA recall Z-2599-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-04

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-05-04, terminated 2020-08-07. It names one FDA 510(k) clearance: K020160. Product: MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.. Reason: The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Terminated: 2020-08-07
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K020160 — DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLINDade Behring, Inc.·cleared 2002-03-14

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

MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

Reason for recall

The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

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