ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chem

FDA device recall Z-1146-2014 · posted 2014-03-05 · Terminated

Recall details

Recalling firm

Horiba Instruments, Inc dba Horiba Medical

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

Action taken

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

Status

Terminated

Product code

JIX

Quantity affected

2,023 units

Distribution

United States nationwide distribution.

Date initiated

2014-01-20

Date posted

2014-03-05

Date terminated

2014-12-05

Location

Irvine, CA

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