ABX Pentra AST CP recall
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate…
Why was ABX Pentra AST CP recalled?
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
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: 00456-4108
- Product
- ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate…
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 66886 units
- Distribution
- Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
- Recall date
- January 9, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)