Recall Z-1371-2021— Beckman Coulter Inc.

Name: FDA recall Z-1371-2021
Creator: U.S. Food and Drug Administration
Published: 2019-09-04

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2019-09-04, terminated 2023-01-11. It names one FDA 510(k) clearance: K911400. Product: MicroScan WalkAway-96 plus Instrument. Reason: Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-09-04
Terminated: 2023-01-11
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 Instrument

Reason for recall

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

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