Royal Shield Non-Sterile Bubble Gum Scented Powder-Free Latex Examination Glove with Protein Content Labeling Claim (5O

• • Terminated Z-2308-2016 FDA Class II ·initiated 30 Jul 2015 ·on shared 510(k) K991743

  Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K991743 ↗

FDA Product Code

LYY

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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