Recall Z-1674-2020— Beckman Coulter Inc.

Name: FDA recall Z-1674-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-13

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2019-12-13, terminated 2021-04-30. It names one FDA 510(k) clearance: K820299. Product: Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.. Reason: Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-13
Terminated: 2021-04-30
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K820299 — PROMPT INOCULATION SYSTEM3M Company·cleared 1982-03-15

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

Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.

Reason for recall

Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.

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