Activated Whole Blood Clotting Time

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

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 detected prior to handling.

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

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.

Celite ACT Cartridge

Celite ACT cartridges have increased numbers of values outside the accepted allowable error.

i-STAT ACT Celite Cartridges

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 of the cartridge.

i-STAT ACT Kaolin Cartridges

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 of the cartridge.

Abbott i-STAT ACT Celite Cartridges.

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 should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.

Abbott i-STAT ACT Kaolin Cartridges.

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 should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.

Hemochron Jr. ACT- LR Assay (JACT- LR);

One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.

Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in indivi

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 Donor Blood as media.

i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.

Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.