Drug recall

Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product…

FDA recall event 85137 · Class II · Beckman Coulter Inc.

Key facts

Event ID 85137
Recall numbers Z-1674-2020
Recalling firm Beckman Coulter Inc.
Product type Devices
Products 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…
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
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…
Initiation date Dec 13, 2019
Report date Apr 15, 2020
Termination date Apr 30, 2021
City Brea
State CA
Country United States
FEI number 2050012

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

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