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 The Cascade…
Why was Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO recalled?
Due to some cards in this lot experiencing variations in 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: 1-15-5701 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 The Cascade…
- Recalling firm
- Helena Laboratories, Inc.
- Quantity
- 12 Kits
- Distribution
- US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)