Z-1173-2007

ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company

Name: Z-1173-2007 ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
Creator: Sendx Medical Inc
Published: 2007-06-19
License: https://open.fda.gov/license/

Sendx Medical, Inc. / initiated 2007-06-19 / Terminated / root cause: labeling and UDI

FDA source

Sendx Medical Inc began a recall of ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company on 2007-06-19. The reason FDA records is "Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1173-2007
Status: Terminated
Initiated: 2007-06-19
Posted: 2007-08-18
Terminated: 2011-11-07
Recalling firm: Sendx Medical, Inc.
Product: ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A total of four (4) distributors were sent the recall package (Field Action Notice) by email on 6-29-07. The distributors were provided background information and specific instruction that all Cal packs from lot 17323 should be removed from customer sites and destroyed. The Recall package included a Management Cover for Field Action Notes, a Customer Letter and the Field Action Notice #915-261. All communications regarding field actions associated with this recall were distributed using the Radiometer Field Action Note (FAN) system.
Quantity in commerce: 69
Distribution: Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.
Product codes and lots: Lot Number 17323

Product code CHL

K994346Class IIAbl 77 Ph, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. / cleared 2000-02-01

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)