Class 1 Recall: Biosite Incorporated, Triage Cardiac Panel

Triage Cardiac Panel, Catalog No. 97000HS, Lot #W44467B, shipped as 25 individually pouched devices per kit box. (This recall is limited only to this catalog and lot number).

The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have.

Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week).

On April 27, 2009, the company sent an urgent recall notice with an attached “Customer/Distributor Verification Form” by FAX, email, or direct mail. Customers were:

• Informed of the reason for the recall.
• Instructed to immediately discontinue all use of the products.
• Instructed to discard all affected products according to their regulations.
• Given two options.
• Option 1: To complete and FAX the enclosed Verification Form within 10 days to confirm receipt of the notice and to indicate the number of kits discarded from their inventory and number of product replacements to be sent to them.
• Option 2: To contact Inverness Medical Technical Services at 1-877-441-7440 (select option 2 from the phone prompt). A company representative would confirm the number of kits discarded from the customer’s inventory and arrange for replacement products to be sent to them.
• Provided with Biosite’s telephone, FAX, and email contact if there were any questions dealing with the recall notice.

For more information about this recall, please see the company’s press release.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178