The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1674-2020·Announced 2020-04-15

Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands

Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the defect could lead to incorrect clinical test results (false-susceptible or false-resistant), which poses a risk of harm through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses have been reported.

Plain-English summary

Beckman Coulter Inc. is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561. The affected units are from Lot number 20201103T with an expiration date of 11/3/2020. The product is used to standardize inocula for microdilution antimicrobial susceptibility tests.

The recall was initiated due to customer reports that the inoculation system contains incorrect prompt wands. The use of these incorrect wands could result in false-susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.

The affected products were distributed worldwide, including nationwide in the United States and in Canada, China, Japan, and Paraguay. Users should stop using the affected units and contact Beckman Coulter for further instructions.

The recalled product

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.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
3,472

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot number 20201103T
  • Expiration Date: 11/3/2020

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

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