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U.S. Department of Health and Human Services

Class 1 Device Recall Triage Cardiac Panel

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  Class 1 Device Recall Triage Cardiac Panel see related information
Date Initiated by Firm April 27, 2009
Date Posted May 08, 2009
Recall Status1 Terminated 3 on July 06, 2010
Recall Number Z-1391-2009
Recall Event ID 51925
510(K)Number K030286  
Product Classification Cardiac Markers Test - Product Code MMI
Product Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box.

Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determination of myoglobin, creatine kinase MB fraction (CK-MB), and troponin I in EDTA whole blood and plasma specimens. These three cardiac biomarkers are used as an aid in the diagnosis of myocardial infarction (injury).
Code Information Lot Number W44467B
Recalling Firm/
Manufacturer		 Biosite Inc
9975 Summers Ridge Rd
San Diego CA 92121
For Additional Information Contact
858-455-4808 Ext. 3015
Manufacturer Reason
for Recall		 The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis.
FDA Determined
Cause 2		 Process control
Action The recall was initiated with "Urgent Medical Device Recall" notices, dated 4/28/2009, with attached "Customer/Distributor Verification Form" being sent to the affected customers via fax, e-mail or direct mail on 04/28/2009. Customers were informed of the reason for the recall and instructed to immediately discontinue all use of the listed products and discard all affected product in accordance with your their regulations. The customers were give two options; "Option 1: Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice, to indicate the number of kits discarded from your inventory and product replacement will be sent to you. Option 2: Contact inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt. A representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you." Customers were also provided telephone, fax and e-mail contact information for Biosite should they have any questions about the information contained in the recall notification.
Quantity in Commerce 401 kits
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMI and Original Applicant = BIOSITE INCORPORATED
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