Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

FDA Device Recall #Z-0032-2022 — Class II — August 9, 2021

Recall Summary

Recall Number Z-0032-2022
Classification Class II — Moderate risk
Date Initiated August 9, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Beckman Coulter Inc.
Location Brea, CA
Product Type Devices
Quantity 293,640 kits

Product Description

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

Reason for 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.

Distribution Pattern

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, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, China, Croatia, Cura¿ao, Czech Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vietnam, Yemen, and Zimbabwe

Lot / Code Information

Catalog Number:B52699 Lot Number / UDI Code: 921491 / (01)15099590693183(17)201130(11)191201(10)921491; 921638 / (01)15099590693183(17)201231(11)200101(10)921638; 921631 / (01)15099590693183(17)210131(11)200201(10)921631; 921750 / (01)15099590693183(17)210131(11)200201(10)921750; 921805 / (01)15099590693183(17)210228(11)200229(10)921805; 921831 / (01)15099590693183(17)210331(11)200331(10)921831; 921943 / (01)15099590693183(17)210430(11)200430(10)921943; 922000 / (01)15099590693183(17)210531(11)200531(10)922000; 922039 / (01)15099590693183(17)210630(11)200630(10)922039; 922040 / (01)15099590693183(17)210731(11)200731(10)922040; 922062 / (01)15099590693183(17)210731(11)200731(10)922062; 922145 / (01)15099590693183(17)210831(11)200831(10)922145; 922146 / (01)15099590693183(17)210930(11)200930(10)922146; 922338 / (01)15099590693183(17)210930(11)200930(10)922338; 922440 / (01)15099590693183(17)211031(11)201031(10)922440; 922545 / (01)15099590693183(17)211031(11)201031(10)922545; 922547 / (01)15099590693183(17)211130(11)201130(10)922547; 922713 / (01)15099590693183(17)211231(11)201231(10)922713; 922714 / (01)15099590693183(17)211231(11)201231(10)922714; 922722 / (01)15099590693183(17)220131(11)210131(10)922722; 922897 / (01)15099590693183(17)220131(11)210131(10)922897; 124235 / (01)15099590693183(17)220228(11)210228(10)124235; 124339 / (01)15099590693183(17)220228(11)210228(10)124339; 922898 / (01)15099590693183(17)220228(11)210228(10)922898; 124340 / (01)15099590693183(17)220331(11)210331(10)124340; 124348 / (01)15099590693183(17)220430(11)210430(10)124348; 124353 / (01)15099590693183(17)220430(11)210430(10)124353; 124688 / (01)15099590693183(17)220430(11)210430(10)124688; 124354 / (01)15099590693183(17)220531(11)210531(10)124354; 124355 / (01)15099590693183(17)220630(11)210630(10)124355; 124356 / (01)15099590693183(17)220630(11)210630(10)124356; 124357 / (01)15099590693183(17)220630(11)210630(10)124357;

Other Recalls from Beckman Coulter Inc.

Recall # Classification Product Date
Z-0541-2026 Class II DxFLEX Flow Cytometer Catalog Number C78500 UD... Sep 22, 2025
Z-0441-2026 Class II SYNCHRON Systems Direct LDL Cholesterol (LDLD) ... Sep 17, 2025
Z-0071-2026 Class II SYNCHRON Systems Phosphorus (PHOSm) Reagent RE... Sep 3, 2025
Z-2574-2025 Class II UniCel DxH 800 COULTER Cellular Analysis System... Aug 13, 2025
Z-2573-2025 Class II UniCel DxH 690T COULTER Cellular Analysis Syste... Aug 13, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Beckman Coulter Inc. Recalls by Firm Recall Reasons Device Safety Stats