Helena Laboratories, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2434-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 14, 2016

Date Posted: September 11, 2019

Recall Number: Z-2434-2019

Event ID: 81383

Reason for Recall:

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

Status: Terminated

Product Quantity: 65 kits

Code Information:

Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136) LOT 1-16-5136 EXP 3-17 Model/Catalog Number: 5136 UDI: Primary DI - M52551360

Distribution Pattern:

Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea

Voluntary or Mandated:

Voluntary: Firm initiated