CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
"Free and Total Protein S Elisa Kit" recalled by Helena Laboratories
Helena Laboratories is recalling "Free and Total Protein S Elisa Kit", distributed nationwide in the US. The recall was initiated on 4 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0106-2019
- FDA event ID
- 81024
- Recalling firm
- Helena Laboratories, Beaumont, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Apr 2017
- FDA classified
- 12 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Apr 2017 | Recall initiated by company | |
| 12 Oct 2018 | Classified by FDA | +556 days |
| 24 Oct 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
"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"
Where it was distributed
International distribution to country of: Jordan
Questions about this recall
Is "Free and Total Protein S Elisa Kit" recalled?
Yes. Helena Laboratories recalled "Free and Total Protein S Elisa Kit" on 4 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-0106-2019.
Why was it recalled?
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.
Which lots are affected?
3-16-5292; UDI: Primary DI - M52552920
Where was it sold?
International distribution to country of: Jordan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Helena Laboratories
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Serrated Blade Applicator Kit (12 Sample) recalled | Helena Laboratories | Packaging Defects | 8 states |
| Device | CLASS II | V8 Immunodisplacement Kit recalled by Helena Laboratories | Helena Laboratories | Other | 4 states |
| Device | CLASS II | Cascade Abrazo aPTT Test Card recalled by Helena Laboratories | Helena Laboratories | Other | Nationwide |
| Device | CLASS II | K-act Actalyke Clotting Test Tubes that are used recalled | Helena Laboratories | Device Malfunction | Nationwide |
| Device | CLASS III | Collagen Reagent recalled by Helena Laboratories | Helena Laboratories | Particulate Matter | 10 states |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |