Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1173-2007 · Posted 2007-08-18

Recalling FirmSendx Medical Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2007-06-19
Date Terminated2011-11-07
Product Quantity69

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K994346ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEMSendx Medical, Inc. · 2000-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑