The Recall Desk
HighFDA (Devices)·Z-0091-2018·Announced 2017-11-22

Beckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk

Beckman Coulter is recalling 268 AQUIOS CL Flow Cytometers because the system may duplicate sample requests, leading to sample misidentification when connected to a Laboratory Information System.

What this means for you

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 is classified as FDA Class II, and the hazard involves sample misidentification, which poses a risk of harm to patients through incorrect diagnostic results, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Beckman Coulter Inc. is recalling 268 units of the AQUIOS CL Flow Cytometer, Catalog No. B30166. The device is an in vitro diagnostic instrument intended for immunophenotyping and is used with specific monoclonal antibody reagents and software. The recall is due to a software defect where the system may duplicate sample requests, which can lead to sample misidentification when the device is connected to a Laboratory Information System (LIS).

The affected units were distributed worldwide, including in the United States (AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, WA, and Puerto Rico) and in numerous international locations. The recall covers all existing software versions 2.0, 2.0.1, and 2.1. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and laboratories using the AQUIOS CL Flow Cytometer should contact Beckman Coulter Inc. for instructions on how to resolve the issue. Users should verify sample identification protocols to prevent potential misidentification of patient samples.

The recalled product

Product
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagen
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
268

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 (3)

  • All existing software versions (2.0
  • 2.0.1
  • and 2.1).

Distribution

Distributed in 16 states:

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