Z-0588-2017Class II

Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5...

Name: Z-0588-2017 Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5...
Creator: Alere San Diego, Inc.
Published: 2016-10-12
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2016-10-12 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to... on 2016-10-12. FDA classified it as Class II and gives the reason as "Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card". 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-0588-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Posted: 2016-11-16
Terminated: 2017-07-24
Recalling firm: Alere San Diego, Inc.
Product: Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Alere, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 10/2016 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of and discard the CODE Chip contained within the Alere Triage Total 5 Control Level 1 PN 88753 Lot C3233A; install the replacement QC Sample CODE Chip for Lot C3233AR; share this information with your laboratory staff and retain this notification as part of your laboratory QS documentation; if you have forwarded the product to another laboratory, provide copy of this notification; and complete and return the Customer/Distributor Verification Form via Fax to Alere Technical Services at +1 858 805 8457 within 10 business days. Customer with any questions about the information contained in the notification are instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121, U.S.A. Phone: 844-320-5124 FAX: 858-805-8457 E-mail: [email protected] On 11/10/16 a revised Urgent Medical Device Correction letter was sent to their customers to inform them of the recall.
Quantity in commerce: 513 kits
Distribution: US Nationwide Distribution
Product codes and lots: C3233A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0588-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0588-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

Product code JJY

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

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)