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Lower risk Medical device recall · FDA · Published May 7, 2021

Beckman Coulter Access SARS CoV-2 lgG II Reagent Recall: False High Results Risk

Beckman Coulter recalls Access SARS CoV-2 lgG II Reagent (REF: C69057) due to potential false high results from specific software versions. All lots affected.

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

🇺🇸 FDA recall #Z-1905-2021Medical deviceBeckman Coulter ›
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Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling its Access SARS CoV-2 lgG II Reagent (REF: C69057) because certain software versions can multiply test results by 1000, causing falsely high readings. This could lead to incorrect health assessments if used without updating the software. Read more at govinfonow.com/recall/62587-beckman-coulter-access-sars-cov-2-lgg-ii-reagent-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/62587-beckman-coulter-access-sars-cov-2-lgg-ii-reagent-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1905-2021

Cite this page

“Beckman Coulter Access SARS CoV-2 lgG II Reagent Recall: False High Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62587-beckman-coulter-access-sars-cov-2-lgg-ii-reagent-recall. Based on FDA recall #Z-1905-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1905-2021%22&limit=1).

The FDA announced on May 7, 2021, that Beckman Coulter Inc. is recalling Access SARS-CoV-2 IgG II Reagent (REF: C69057) because assay protocol file issues may cause falsely elevated numerical results. The recall affects all lots of the product distributed in the U.S., Puerto Rico, and several international locations.

How to tell if you have it

  • Brand: Beckman Coulter
  • Product: Access SARS-CoV-2 IgG II Reagent
  • REF: C69057
  • IVD CE UDI: (01)15099590742744
  • UPC: 15099590742744
  • Lots: All Lots

The hazard

SARS-CoV-2 IgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with specific assay protocol file (APF) and access assay file (AAF) versions. This error results in falsely elevated numerical values.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since June 20, 2017. Recent brand recalls include the DxC 500i Clinical Analyzer Modules recall on Sept. 2, 2026, and the DxC 500 AU Modules recall on July 15, 2026. Other recent recalls of similar products include the Beckman Coulter LDL Cholesterol Reagent recall (Dec. 8, 2025), the Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).

How to tell if you have this one

Check for the reagent product name 'Access SARS CoV-2 lgG II Reagent' with reference number REF: C69057. All lots are affected by this recall.

  • Brand
    Beckman Coulter
  • Product
    Beckman Coulter Inc. recalls Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming, OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates
Recall numberProduct, codes & lotsQuantity
Z-1905-2021Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744; All Lots13,337 units
Z-1906-2021Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751; All Lots3,843 units
Based on the official FDA remedy

What to do — step by step

  1. Update Software Versions

    Ensure your system uses the latest software versions to prevent false results.

Where it went and when

Where it was distributed

Distributed in 30 states and Puerto Rico, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: not listedVTNew Hampshire: yesNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: yesNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: yesWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: May 7, 202112. FDA classified it Class II: Jun 21, 202123. Published in FDA’s Enforcement Report: Jun 30, 202134. FDA terminated the recall: Mar 27, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-1905-2021 (May 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1905-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA