Home › Device types › JBP
Activated Whole Blood Clotting Time
FDA product code JBP · Class 2 · Hematology
53
Registered devices
321
Adverse events
10
Recalls
24
510(k) clearances
Devices with this code
NA — MEDTRONIC, INC.LR-ACT — MEDTRONIC, INC.CLOTtrac™ — MEDTRONIC, INC.CLOTtrac® — MEDTRONIC, INC.CLOTtrac™ — MEDTRONIC, INC.CLOTtrac® — MEDTRONIC, INC.CLOTtrac™ — MEDTRONIC, INC.CLOTtrac™ — MEDTRONIC, INC.CLOTtrac™ — MEDTRONIC, INC.Sonoclot® Coagulation & Platelet Function Analyzer — SIENCO, INC.NA — MEDTRONIC, INC.Actalyke Mini II, w/ Printer, w/o Battery, "CE" (110V/220V) — HELENA LABORATORIES CORPORATIONSonoclot® aiACT Kit — SIENCO, INC.Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.K-ACT Tubes — HELENA LABORATORIES CORPORATIONHR HTC — MEDTRONIC, INC.Sonoclot® gbACT+ Kit — SIENCO, INC.i-STAT — ABBOTT POINT OF CARE INC.Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.CLOTtrac™ — MEDTRONIC, INC.CLOTtrac® — MEDTRONIC, INC.Actalyke MAX-ACT Tubes — HELENA LABORATORIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-05 | Accriva Diagnostics, Inc. | Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not |
| 2025-10-20 | Medtronic Perfusion Systems | Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. |
| 2010-12-03 | Abbott Point Of Care Inc. | Celite ACT cartridges have increased numbers of values outside the accepted allowable error. |
| 2010-10-06 | Abbott Point Of Care Inc. | Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port |
| 2010-10-06 | Abbott Point Of Care Inc. | Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port |
| 2009-08-18 | Abbott Point of Care Inc. | Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes sho |
| 2009-08-18 | Abbott Point of Care Inc. | Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes sho |
| 2009-05-05 | International Technidyne Corp. | One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria. |
| 2005-04-27 | International Technidyne Corp. | Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Do |
| 2005-03-16 | Abbott Laboratories | Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer. |
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