Cascade Abrazo C-act-lr Test Card IVD for in Vitro recall
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
Why was Cascade Abrazo C-act-lr Test Card IVD for in Vitro recalled?
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
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 Codes: 1-16-5701 Model/Catalog Number: 5701
- Product
- Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
- Recalling firm
- Helena Laboratories, Inc.
- Quantity
- 27 kits
- Distribution
- US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
- Recall date
- December 12, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)