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.

Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

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.