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U.S. Department of Health and Human Services

Class 2 Device Recall Triage Total Controls 5, Level 1

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  Class 2 Device Recall Triage Total Controls 5, Level 1 see related information
Date Initiated by Firm February 06, 2009
Date Posted June 11, 2010
Recall Status1 Terminated 3 on September 01, 2011
Recall Number Z-1788-2010
Recall Event ID 54276
510(K)Number K072892  
Product Classification multi-analyte controls, all kinds (assayed) - Product Code jjy
Product Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C.

Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to assist in monitoring test performance.
Code Information Model 88753 Lots C1916A, C1931A, C1932A & C1999A
Recalling Firm/
Manufacturer		 Biosite Inc
9975 Summers Ridge Rd
San Diego CA 92121
Manufacturer Reason
for Recall		 Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
FDA Determined
Cause 2		 Other
Action The firm, Biosite Incorporated, sent an "URGENT MEDICAL DEVICE RECALL" dated February 6, 2009, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to immediately discontinue all use and/or sale of the listed products, discard all affected product in accordance with their local regulations, complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice, to indicate the number of kits discarded from their inventory and the product replacement will be sent to them. Contact Inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt and a representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you. Should you have any questions about the information contained in this notification, please contact (877) 441-7440 or email: Recalls@biosite.com
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 = jjy and Original Applicant = BIOSITE INCORPORATED
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