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Recall Observatory FDA recall evidence

Device product

HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769

Z-1585-2022

May 25, 2022

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 90336
Status
Ongoing
Classification
Class II
Quantity
3 each
Official record key
device-enforcement:Z-1585-2022

Official wording

Reason: 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.

Code information: GTIN: 03610230005514 Lots Distributed:5/30/2021 - 6/9/2021

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.