AQUIOS CL Flow Cytometer — Class II medical device recall Z-0091-2018

Terminated recall by Beckman Coulter Inc., reported 2017-11-22, distributed in AZ, CA, CO, FL, GA, IL, IN, KS…. The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory In

Recall number	`Z-0091-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Beckman Coulter Inc., Brea, CA, United States
Recall initiated	2017-10-02
Classified	2017-11-15
Reported by FDA	2017-11-22
Terminated	2019-05-08
Distributed	AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, PR, SC, TX, WA
Countries outside the US	AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GH, HK, IL, IN, IT, KE, MX, MY, NL, NO, NZ, PA, PK, PL, PT, RO, SE, SK, TR, UA, ZA
Quantity	268 units
Model numbers	`B30166`

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 reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.

Reason for recall

The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0091-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.