Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence

FDA device recall Z-1391-2009 · posted 2009-05-08 · Terminated

Recall details

Recalling firm

Biosite Inc

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

MMI

Quantity affected

401 kits

Distribution

Nationwide Distribution

Date initiated

2009-04-27

Date posted

2009-05-08

Date terminated

2010-07-06

Location

San Diego, CA

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