Biosite Inc: 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).

Recall number

Z-1391-2009

Recalling firm

Biosite Inc

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).

Status

Terminated

Initiated

2009-04-27

Posted

2009-05-08

Terminated

2010-07-06

Reason

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.

Root cause

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

401 kits

Distribution

Nationwide Distribution

Lot, serial or model codes

Lot Number W44467B

510(k) numbers

["K030286"]

PMA numbers

not on file

Product code

MMI

Firm FEI

1000125596

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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