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Recall Observatory FDA recall evidence

Device product

LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.

Z-1919-2015

April 29, 2015

Class II

Product summary

Firm
LifeHealth, LLC
Event
Event 71292
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-1919-2015

Official wording

Reason: The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.

Code information: 44803, 44805, 44807, 44808, 44818, 44830, 44837

Distribution pattern: Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.