Recall Z-0045-2020 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Helena Laboratories, Corp.
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
| Date | Jul 21, 2017 |
| Status | Terminated |
| Reason | The plates do not have wells punched for the controls in the patient 1 area. |
| Root cause | Employee error |
| Action | The recall was initiated via phone on 7/21/2017 requesting the customer return the product for replacement if they routinely use the control wells. |
| Quantity | 24 kits |
| Distribution | Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973040 | SPIFE IFE-6 Helena Laboratories, Jan 2, 1998 |