Helena Laboratories, Corp.
FDA Regulatory Profile
Helena Laboratories, Corp. appears in FDA public data with 16 recalls, 282 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1975-2023, Class II) was initiated on May 2, 2023. Its most recent 510(k) clearance was granted on October 13, 2022.
Summary
- Total Recalls
- 16
- 510(k) Clearances
- 282
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1975-2023 | Class II | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Content | May 2, 2023 |
| Z-1244-2022 | Class II | V8 Immunodisplacement Kit REF 1803 | April 6, 2022 |
| Z-1108-2021 | Class II | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and a | January 5, 2021 |
| Z-0635-2021 | Class II | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZE | November 9, 2020 |
| Z-1950-2019 | Class II | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on t | August 8, 2018 |
| Z-1949-2019 | Class II | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on | August 8, 2018 |
| Z-0537-2020 | Class III | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collag | May 23, 2018 |
| Z-0536-2020 | Class III | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL AD | May 23, 2018 |
| Z-0297-2020 | Class III | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemo | February 27, 2018 |
| Z-2761-2019 | Class II | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena La | December 7, 2017 |
| Z-0045-2020 | Class II | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the labe | July 21, 2017 |
| Z-0106-2019 | Class II | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Pro | April 4, 2017 |
| Z-0561-2019 | Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORA | February 24, 2017 |
| Z-0529-2019 | Class III | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. N | November 7, 2016 |
| Z-2434-2019 | Class II | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL | October 14, 2016 |
| Z-0594-2019 | Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORA | April 20, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213396 | SPIFE A1AT kit | October 13, 2022 |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | April 19, 2022 |
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | October 7, 2013 |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | December 15, 2010 |
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | February 23, 2007 |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALE | July 6, 2006 |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | May 10, 2006 |
| K050053 | HEMORAM/AGGRAM ANALYZER | July 11, 2005 |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | February 19, 2003 |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | February 14, 2003 |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | October 11, 2002 |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | October 1, 2002 |
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | August 15, 2002 |
| K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | May 23, 2002 |
| K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | May 6, 2002 |
| K020467 | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | March 29, 2002 |
| K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | January 10, 2002 |
| K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | December 21, 2001 |
| K012723 | PLATELETWORKS | September 28, 2001 |
| K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT | March 15, 2001 |