Reported Mar 12, 2014 · Terminated
ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical…
Horiba Instruments, Inc. dba Horiba Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Horiba Instruments, Inc dba Horiba Medical · 34 Bunsen · Irvine, CA · 92618-4210
Is this the product you have?
- ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers
- using two measuring principalsabsorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml
- Lot codes and dates
- Model Numbers
Multical - A11A01652N Control - A11A01653P Control - A11A01654
- Lot NumbersMultiCal: 1204101 and 1304901
- N Control1300801
- P Control1300601
- Expiration Date (s)MultiCal: 1204101 Expires on 05/31/14
- MultiCal1304901 Expires on 07/15/15
- N Control1300801 Expires on 11/05/14
- P Control1300601 Expires on 11/05/14
- Model Numbers
- Amount recalled
- 2,023 units
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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