Lower risk Medical device recall · FDA · Published August 9, 2021

Beckman Coulter Access hsTnI Troponin I Reagent Pack Recall: Carryover Risk

Beckman Coulter recalls Access hsTnI High Sensitivity Troponin I reagent packs with specific lot numbers due to potential sample carryover causing contamination in high concentration tests.

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

🇺🇸 FDA recall #Z-0032-2022Medical device Beckman Coulter ›

Lower-risk recall

Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.

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 certain Access hsTnI High Sensitivity Troponin I reagent packs. Using these packs with very high troponin I concentrations may cause contamination that affects test results. This could lead to inaccurate cardiac tests if not addressed. Read more at govinfonow.com/recall/62008-beckman-coulter-access-hstni-troponin-i-reagent-pack-recall-carryover.

Source Summary by GovInfoNow · govinfonow.com/recall/62008-beckman-coulter-access-hstni-troponin-i-reagent-pack-recall-carryover · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0032-2022

Cite this page

“Beckman Coulter Access hsTnI Troponin I Reagent Pack Recall: Carryover Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62008-beckman-coulter-access-hstni-troponin-i-reagent-pack-recall-carryover. Based on FDA recall #Z-0032-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0032-2022%22&limit=1).

The FDA announced on Aug. 9, 2021, that Beckman Coulter Inc. is recalling Access hsTnI High Sensitivity Troponin I reagent packs due to potential sample carryover hazards. The agency issued recall number Z-0032-2022 for the device.

How to tell if you have it

Brand: Beckman Coulter
Product: Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
UPC: 15099590693183
Lot Numbers: 921491, 921638, 921631, 921750, 921805, 921831, 921943, 922000, 922039, 922040, 922062, 922145, 922146, 922338, 922440, 922545, 922547, 922713, 922714, 922722, 922897, 124235, 124339, 922898, 124340, 124348, 124353, 124688, 124354, 124355, 124356, 124357
Quantity: 293,640 kits

The hazard

According to the FDA, testing a sample with cardiac troponin I concentration greater than 270,000 pg/mL may cause carryover into the hsTnI reagent pack. This carryover occurs predominantly into the particle well of the reagent pack via the probe, contaminating it with the high sample. The extent of the carryover depends on sample concentration and frequency.

Context

GovInfoNow's records show Beckman Coulter has 133 other recalls on record since June 20, 2017. Other recent recalls include DxC 500 AU Clinical Chemistry Analyzers (Sept. 2, 2026), DxC 500i Modules with Software 1.5 Risk (July 15, 2026), and MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026). Other recent recalls of similar products include Emit 2000 Quinidine Assay Recall (July 13, 2026) and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).

How to tell if you have this one

Check the lot number on the reagent pack. The affected lots include 921491, 921638, 921631, 921750, 921805, 921831, 921943, 922000, 922039, 922040, 922062, 922145, 922146, 922338, 922440, 922545, 922547, 922713, 922714, 922722, 922897, 124235, 124339, 922898, 124340, 124348, 124353, 124688, 124354, 124355, 124356, 124357.

Brand
Beckman Coulter
Product
Beckman Coulter Inc. recalls Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Reagent Lot Number
Look for the lot number on the reagent pack to determine if it is affected. Affected lots are listed in the recall.

Where it went and when

Where it was distributed

Distributed in 43 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY O.U.S.: Algeria, Andorra,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

Aug 9, 2021Firm started the recall
Oct 5, 2021FDA classified it Class II
Oct 13, 2021Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/62008-beckman-coulter-access-hstni-troponin-i-reagent-pack-recall-carryover">Beckman Coulter Access hsTnI Troponin I Reagent Pack Recall: Carryover 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-0032-2022 (August 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0032-2022 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.