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Terminated

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 principals: absorbance 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.

FDA Recall Z-1146-2014 · Posted 2014-03-05

Recalling FirmHoriba Instruments, Inc dba Horiba Medical
Recall StatusTerminated
Product CodeJIX
Date Initiated2014-01-20
Date Terminated2014-12-05
Product Quantity2,023 units

Reason for Recall

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

Firm Action

HORIBA Medical initiated this recall by sending customers recall communication via FedEx week of January 20, 2014. The recall communication was a Field Safety Notice letter and Acknowledgement Form. The letter, dated 01/20/2014, titled "URGENT SAFETY NOTICE", informed customers of the recall by providing product description and codes, issue, impact, actiona/resolution, and contact information. The letter contained the following attachments: Field Safety Notice Acknowledgement Form and Updated Annexes with re-assigned values.

Root Cause

Under Investigation by firm

Distribution Pattern

United States nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110530ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROLHORIBA ABX SAS · 2012-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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