Z-1391-2009

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

Name: Z-1391-2009 Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box...
Creator: Biosite Inc
Published: 2009-04-27
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2009-04-27 / Terminated / root cause: manufacturing process

FDA source

Biosite Inc began a recall of Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence immunoassay kit to be used with the... on 2009-04-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1391-2009
Status: Terminated
Initiated: 2009-04-27
Posted: 2009-05-08
Terminated: 2010-07-06
Recalling firm: Alere San Diego, 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).
Product code: MMI Immunoassay Method, Troponin Subunit
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 401 kits
Distribution: Nationwide Distribution
Product codes and lots: Lot Number W44467B

Product code MMI

K030286Class IITriage Cardio Profiler/triage Cardiac PanelBiosite Incorporated / cleared 2003-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)