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ABX PENTRA ETCHING CP 1220001769Recalls & reported problems

Horiba Abx Sas · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K052007); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. May 25, 2022Class IIOpen, Classified

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

    Z-1585-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052007. One submission often covers many models, so check the product and lot details in each record.

  • Z-0493-2018 · Nov 21, 2017 · Terminated
    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
  • Z-0494-2018 · Nov 21, 2017 · Terminated
    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
  • Z-0740-2016 · Jan 11, 2016 · Terminated
    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxida
  • Z-0902-2015 · Nov 13, 2014 · Terminated
    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
  • Z-0904-2014 · Nov 21, 2013 · Terminated
    ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in
  • Z-1141-2013 · Mar 20, 2013 · Terminated
    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion el

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Sources and updates

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