Z-1790-2010

Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels...

Name: Z-1790-2010 Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels...
Creator: Biosite Inc
Published: 2009-02-06
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2009-02-06 / Terminated

FDA source

Biosite Inc began a recall of Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C. Intended use... on 2009-02-06. The reason FDA records is "Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1790-2010
Status: Terminated
Initiated: 2009-02-06
Posted: 2010-06-11
Terminated: 2011-09-01
Recalling firm: Alere San Diego, Inc.
Product: Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C. Intended use: Materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to verify the calibration of the Test Devices throughout the measurable range.
Product code: jjy
Reason for recall: Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
FDA root cause: Other
Action: The firm, Biosite Incorporated, sent an "URGENT MEDICAL DEVICE RECALL" dated February 6, 2009, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to immediately discontinue all use and/or sale of the listed products, discard all affected product in accordance with their local regulations, complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice, to indicate the number of kits discarded from their inventory and the product replacement will be sent to them. Contact Inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt and a representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you. Should you have any questions about the information contained in this notification, please contact (877) 441-7440 or email: [email protected]
Distribution: Nationwide distribution
Product codes and lots: Model 88755 Lots 194444 & 194450

Product code jjy

K072892Class ITriage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated / cleared 2007-12-07

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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)