Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: Assayed materials used with the

FDA device recall Z-1788-2010 · posted 2010-06-11 · Terminated

Recall details

Recalling firm

Biosite Inc

Reason for recall

Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.

Action taken

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

Root cause

Other

Status

Terminated

Product code

jjy

Distribution

Nationwide distribution

Date initiated

2009-02-06

Date posted

2010-06-11

Date terminated

2011-09-01

Location

San Diego, CA

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