Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t
Summary
The FDA issued a Class II for Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the by Beckman Coulter, Inc.. Reason: Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,.
Details
Source
Device Recall
External ID
Z-0727-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
Lot/Code Info: UDI/DI 15099590693183, All Lots
Quantity Affected: 2,109,804 units
Reason for Recall
Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-18
Company
Chaska, MN
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 119 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-0727-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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