The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1341-2018·Announced 2018-04-18

Beckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors

Beckman Coulter is recalling 288 AQUIOS CL Flow Cytometer Systems because the single tube loader may process the same sample with two different IDs, potentially causing erroneous 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 is classified as FDA Class II. The hazard involves potential erroneous results due to sample mis-identification, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Beckman Coulter Inc. is recalling 288 AQUIOS CL Flow Cytometer Systems (Catalog #B30166) due to a software defect. The device may process the same sample with two different sample IDs and sample information while using the single tube loader. This issue has the potential for erroneous results due to the mis-identification of samples.

The affected devices were distributed nationwide in the U.S. and in Puerto Rico, as well as to various foreign countries. The recall includes all software versions of the device. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.

Healthcare facilities and users should contact Beckman Coulter for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a situation where 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.

The recalled product

Product
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
288

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 (1)

  • All software versions.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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