Hemochron Jr. Whole Blood Microcoagulation System APTT recall
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Why was Hemochron Jr. Whole Blood Microcoagulation System APTT recalled?
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number A4JCA001
- Product
- Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
- Recalling firm
- ITC-Nexus Dx
- Quantity
- US- 315 cuvettes; OUS - 2835 cuvettes
- Distribution
- Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)