Recall Z-2434-2019— Helena Laboratories, Inc.

Name: FDA recall Z-2434-2019
Creator: U.S. Food and Drug Administration
Published: 2016-10-14

Class II · Terminated

Class II FDA medical device recall by Helena Laboratories, Inc., initiated 2016-10-14, terminated 2023-10-12. It names one FDA 510(k) clearance: K821982. Product: Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL. Reason: Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range..

Recalling firm: Helena Laboratories, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-14
Terminated: 2023-10-12
Firm location: Beaumont, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K821982 — TITAN GEL SERUM CONTROLHelena Laboratories·cleared 1982-08-16

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

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

Reason for recall

Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.

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