Horiba Instruments, Inc dba Horiba Medical: ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.

Recall number

Z-0632-2013

Recalling firm

Horiba Instruments, Inc dba Horiba Medical

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 Amino Transferase (AST) in serum or plasma by colorimetry.

Status

Terminated

Initiated

2012-10-10

Posted

2013-01-03

Terminated

2013-09-12

Reason

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.

Root cause

Software design

Action

Horiba Medical sent a Field Safety Notification and Acknowledgement Letter dated November 20, 2012, to all affected customers. The letter notified the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 calendar days via mail, email or fax. Customers with questions were instructed to contact their local representative. For questions regarding this recall call 714-273-9254.

Quantity

66886 units

Distribution

Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

Lot, serial or model codes

Lot number: 00456-4108

510(k) numbers

["K060318"]

PMA numbers

not on file

Product code

CIT

Firm FEI

3002698356

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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