Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25… recallZ-1391-2009 · Biosite Inc · initiated Apr 27, 2009
Terminated All recalls posted in May 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biosite Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1391-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 27, 2009
- Posted by the FDA
- May 8, 2009
- Recalling firm
- Biosite Inc
- Quantity
- 401 kits
- Product code
- MMI
- FDA submissions
- K030286
- Distribution
- Nationwide Distribution
Product description
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).
Code information (models, lots, serial numbers)
Lot Number W44467B
Other devices under the same FDA submission
3 devices cleared under K030286 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Triage 97021HSQuidel Cardiovascular Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall42 reports
- Triage 97000HSQuidel Cardiovascular Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall10 reports
- Triage 97022HSQuidel Cardiovascular Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page