Z-1919-2015Class II

LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro...

Name: Z-1919-2015 LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro...
Creator: LifeHealth, LLC
Published: 2015-04-29
License: https://open.fda.gov/license/

Diametrics Medical, Inc. / initiated 2015-04-29 / Terminated / root cause: manufacturing process

FDA source

LifeHealth, LLC began a recall of 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... on 2015-04-29. FDA classified it as Class II and gives the reason as "The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1919-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-29
Posted: 2015-06-27
Terminated: 2015-10-20
Recalling firm: Diametrics Medical, Inc.
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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were sent via e-mail a LifeHealth LLC " Urgent" letter dated April, 29th, 2015. The letter described the Purpose of this letter, Reason for the Voluntary Recall, Risk to Health, and Actions to be taken by the Customer. Advised consignees to immediately stop using the recalled product and return it to LifeHealth. Requested consignees to complete and return the Acknowledgement and Receipt Form.
Quantity in commerce: 7
Distribution: Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
Product codes and lots: 44803, 44805, 44807, 44808, 44818, 44830, 44837

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1919-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1919-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26

Product code CHL

K945240Class IIIrma Blood Analysis SystemDiametrics Medical, Inc. / cleared 1995-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)