Lower risk Medical device recall · FDA · Published December 2, 2020

Beckman Coulter MicroScan Pos MIC Panel Type 34 Recall: False Elevated MIC Results Risk

Beckman Coulter recalls MicroScan Pos MIC Panel Type 34 due to potential false elevated MIC results for daptomycin testing, affecting clinical isolate accuracy. Affected units may require replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0720-2021Medical device Beckman Coulter ›

Lower-risk recall

Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.

Take action

Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because some units may give false high results for daptomycin testing, which could lead to incorrect antibiotic treatment decisions. This is a quality control issue that affects lab testing accuracy. Read more at govinfonow.com/recall/63724-beckman-coulter-microscan-pos-mic-panel-type-34-recall-false.

Source Summary by GovInfoNow · govinfonow.com/recall/63724-beckman-coulter-microscan-pos-mic-panel-type-34-recall-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0720-2021

Cite this page

“Beckman Coulter MicroScan Pos MIC Panel Type 34 Recall: False Elevated MIC Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63724-beckman-coulter-microscan-pos-mic-panel-type-34-recall-false. Based on FDA recall #Z-0720-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0720-2021%22&limit=1).

The FDA announced on Dec. 2, 2020, that Beckman Coulter Inc. is recalling MicroScan Pos MIC Panel Type 34 due to a potential for false elevated daptomycin susceptibility results. The agency classified the recall as Class II.

How to tell if you have it

Brand: Beckman Coulter
Product: MicroScan Pos MIC Panel Type 34
UPC: 15099590657550
Lot Number: 2021-06-10
Catalog Number: B1017-216
Quantity: 685 panel boxes (13,700 panels)

The hazard

The recall was initiated after a customer report and internal investigation confirmed that a portion of the affected product lot failed quality control for ATCC E. Faecalis 29212 versus daptomycin. This failure creates a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since 2017-06-20. Other recent recalls of similar products include DxC 500i Clinical Analyzer Modules May Show Incorrect Test Results Due to Software Issue (2026-09-02), Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk Patient Test Errors (2026-07-15), and Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit: Incorrect Algorithms May Affect Test Results (2026-06-26). Additional similar recalls include Beckman Coulter Emit 2000 Quinidine Assay Recall: Risk of Incorrect Patient Treatment (2026-07-13), Beckman Coulter REMISOL Advance Software Issue: Incorrect Test Results Risk (2026-04-29), and Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (2026-01-30).

How to tell if you have this one

Check for the lot number 2021-06-10 on the panel. The product is sold under catalog number B1017-216 with UDI code (01)15099590657550(17)210610(11)200610(10)2021-06-10.

Brand
Beckman Coulter
Product
Beckman Coulter Inc. recalls MicroScan Pos MIC Panel Type 34
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Panel Lot Number
Look for the lot number 2021-06-10 on the MicroScan Pos MIC Panel Type 34.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 21 states.

FDA distribution: “U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, IN, KY, MA, MI, MO, NC, NH, NY, OH, OK, PA, SC, SD, TN, TX, VA, and WI. The countries of Australia, Austria, Bahamas, Bangladesh, Bangladesh, Belgium, Brazil,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Michigan, Missouri, New Hampshire, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Dec 2, 2020Firm started the recall
Dec 23, 2020FDA classified it Class II
Dec 30, 2020Published in FDA’s Enforcement Report
Jan 3, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/63724-beckman-coulter-microscan-pos-mic-panel-type-34-recall-false">Beckman Coulter MicroScan Pos MIC Panel Type 34 Recall: False Elevated MIC Results Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0720-2021 (December 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0720-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.