Helena Laboratories, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0106-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX Outer labeling of Substrate (brown bottle and cap): "Substrate 13 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26" Outer Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid): "Protein S Conjugate 12 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26"

Product Classification:

Class II

Date Initiated: April 4, 2017

Date Posted: October 24, 2018

Recall Number: Z-0106-2019

Event ID: 81024

Reason for Recall:

Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.

Status: Terminated

Product Quantity: 3 kits

Code Information:

3-16-5292; UDI: Primary DI - M52552920

Distribution Pattern:

International distribution to country of: Jordan

Voluntary or Mandated:

Voluntary: Firm initiated