Accriva- APTT Cuvette for use on the Hemochron Jr. test recall
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Why was Accriva- APTT Cuvette for use on the Hemochron Jr. test recalled?
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
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 #B6JCA012
- Product
- Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
- Recalling firm
- Accriva Diagnostics Inc., dba ITC, dba Accumetrics
- Quantity
- 135 boxes
- Distribution
- U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
- Recall date
- June 1, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)