Recall Z-0561-2019
Helena Laboratories, Inc. · initiated February 24, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Codes: 1-16-5701 Model/Catalog Number: 5701
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.
FDA-determined cause: Device Design
Action taken
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: jhanka@helena.com
Details
- Recall number
- Z-0561-2019
- Initiated
- February 24, 2017
- Terminated
- October 20, 2023
- Product code
- JPB – Hemoglobin M
- Quantity
- 27 kits
- Distribution
- US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
- Recalling firm
- Helena Laboratories, Inc., Beaumont, TX