Recall Z-0297-2020— Helena Laboratories, Corp.

Name: FDA recall Z-0297-2020
Creator: U.S. Food and Drug Administration
Published: 2018-02-27

Class III · Ongoing

Class III FDA medical device recall by Helena Laboratories, Corp., initiated 2018-02-27. It names one FDA 510(k) clearance: K982426. Product: SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems. Reason: Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users..

Recalling firm: Helena Laboratories, Corp.
Classification: Class III
Status: Ongoing
Initiated: 2018-02-27
Firm location: Beaumont, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K982426 — SPIFE ALKALINE HEMOGLOBINHelena Laboratories·cleared 1998-12-17

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 Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

Reason for recall

Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.

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