Recall Z-1088-2022— Beckman Coulter Inc.

Name: FDA recall Z-1088-2022
Creator: U.S. Food and Drug Administration
Published: 2019-10-21

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2019-10-21. It names one FDA 510(k) clearance: K911400. Product: MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R. Reason: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere.

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-10-21
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K911400 — WALKAWAY TM 40Baxter Healthcare Corp·cleared 1991-11-19

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 WalkAway-96 plus Reconditioned Instrument REF B1018-396R

Reason for recall

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

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