Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Summary
The FDA issued a Class II for Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay Syste by Beckman Coulter Inc.. Reason: Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent p.
Details
Source
Device Recall
External ID
Z-0032-2022
Action Date
2021-10-13
Status
Ongoing
Category
device
Product Description
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Lot/Code Info: 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;
Quantity Affected: 293,640 kits
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
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-09
Company
Brea, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0032-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29