ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P recall
ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two…
Why was ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P recalled?
HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers
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:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654. Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601. Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.
- Product
- ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two…
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 2,023 units
- Distribution
- United States nationwide distribution.
- Recall date
- March 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)