# FDA recall Z-0106-2019 > **Helena Laboratories, Inc.** · Class II · device recall initiated 2017-04-04. ## Product "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" ## 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. ## Distribution International distribution to country of: Jordan ## Key facts - **Recall number:** Z-0106-2019 - **Recalling firm:** Helena Laboratories, Inc. - **Classification:** Class II - **Product type:** device - **Status:** Terminated - **Initiation date:** 2017-04-04 - **Report date:** 2018-10-24 - **Termination date:** 2020-05-14 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Beaumont, TX, United States ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2019 ## Citation > AI Analytics. FDA recall Z-0106-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0106-2019. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*