Recall Z-0045-2020— Helena Laboratories, Corp.

Name: FDA recall Z-0045-2020
Creator: U.S. Food and Drug Administration
Published: 2017-07-21

Class II · Terminated

Class II FDA medical device recall by Helena Laboratories, Corp., initiated 2017-07-21, terminated 2020-06-19. It names one FDA 510(k) clearance: K973040. Product: SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.. Reason: The plates do not have wells punched for the controls in the patient 1 area..

Recalling firm: Helena Laboratories, Corp.
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Terminated: 2020-06-19
Firm location: Beaumont, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K973040 — SPIFE IFE-6Helena Laboratories·cleared 1998-01-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Reason for recall

The plates do not have wells punched for the controls in the patient 1 area.

Data sourced from openFDA. This site is unofficial and independent of the FDA.