Recall Z-0561-2019 ยท JPB Hemoglobin M
Helena Laboratories, Inc.
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
| Date | Feb 24, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 #: |
| Quantity | 27 kits |
| Distribution | US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.