AMS AST For the In vitro quantitative determination of recall
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Why was AMS AST For the In vitro quantitative determination of recalled?
Marketing the devices outside 510(k) requirements
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?
Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.
- Product
- AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
- Recalling firm
- AMS Diagnostics, LLC
- Quantity
- 116 kits
- Distribution
- Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
- Recall date
- April 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)