Recall Z-0937-2014 ยท GFO Activated Partial Thromboplastin
ITC-Nexus Dx
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
| Date | Feb 6, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. |
| Root cause | Device Design |
| Action | The firm, ITC The Point of Care, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2013 a long with an attached Health Professional Account Tracking Form via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to forward this communication to all those within your organization who need to be aware of this matter including any facility that you forwarded any of the affected product to; check all inventory to determine if you have any of the affected lots listed; if you have any affected lots, stop using them, rem |
| Quantity | 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS) |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014008 | HEMOCHRON JR. CITRATE APTT CUVETTE Itc, Inc., Jan 24, 2002 |