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Terminated

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY

FDA Recall Z-0561-2019 · Posted None

Recalling FirmHelena Laboratories, Inc.
Recall StatusTerminated
Product CodeJPB
Date Initiated2017-02-24
Date Terminated2023-10-20
Product Quantity27 kits

Reason for Recall

Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

Firm Action

On 02/24/2017, the firm sent an email to affected users, with a Withdrawal Notification. The firm informed the customers/distributors that Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. On 04/12/2017, the firm mailed formal letters to all customers. PUBLIC CONTACT: "Name: Dr. Jessica Jones Hanka "Title: Technical Services Manager "Address: 1530 Lindbergh Drive, Beaumont, TX 77707 "Telephone #: (409) 842-3714 x1177 "Email: [email protected]

Root Cause

Device Design

Distribution Pattern

US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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