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

FDA device recall Z-0588-2017 · posted 2016-11-16 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

Reason for recall

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

Action taken

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: Responses.ts@alere.com On 11/10/16 a revised Urgent Medical Device Correction letter was sent to their customers to inform them of the recall.

Root cause

Employee error

Status

Terminated

Product code

JJY

Quantity affected

513 kits

Distribution

US Nationwide Distribution

Date initiated

2016-10-12

Date posted

2016-11-16

Date terminated

2017-07-24

Location

San Diego, CA

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