Summary
The FDA issued a Class II for ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 by Abbott Laboratories. Reason: One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component..
Details
Source
Device Recall
External ID
Z-1660-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Lot/Code Info: UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
Quantity Affected: 2451 kits of 100 tests
Reason for Recall
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-26
Company
Abbott Park, IL
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 164 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 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 (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1660-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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