Home › Device types › JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
FDA product code JKA · Class 2 · Clinical Chemistry
0
Registered devices
49,665
Adverse events
171
Recalls
237
510(k) clearances
Devices with this code
LabChoice SecureSafety Safety Blood Collection Sets, Sterile — Dynarex CorporationVacuette — Greiner Bio-One GmbHKBMED — KB Medical (group), Inc.S-Monovette® 1.6ml LH — Sarstedt Aktiengesellschaft & Co.KGGCB Medical Supply — GCB MEDICAL LLCSOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder — Sol-Millennium Medical, Inc.Jelco — ICU MEDICAL, INC.BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes — BECTON, DICKINSON AND COMPANYPortex — ICU MEDICAL, INC.Maveric Medical — MAVERIC MEDICAL LLCPortex — ICU MEDICAL, INC.Vacuette — Greiner Bio-One GmbHS-Monovette® — Sarstedt Aktiengesellschaft & Co.KGULTRAFLO-R — Innovative Medical Technologies, Inc.MEDLINE — MEDLINE INDUSTRIES, INC.Portex — ICU MEDICAL, INC.S-Monovette® — Sarstedt Aktiengesellschaft & Co.KGBD Vacutainer® K2 EDTA (K2E) 10.8 mg Blood Collection Tubes — BECTON, DICKINSON AND COMPANYISOSTAT® Press and Rack — Alere Scarborough, Inc.Portex — ICU MEDICAL, INC.CellSave — MENARINI SILICON BIOSYSTEMS, INC.Portex — ICU MEDICAL, INC.BD Vacutainer® UltraTouch™ Push Button Blood Collection Set — BECTON, DICKINSON AND COMPANYBD Vacutainer® Serum — BECTON, DICKINSON AND COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-29 | Greiner Bio-One North America, Inc. | Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) an |
| 2025-12-19 | ICU Medical Inc. | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to b |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
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