The Recall Desk

Manufacturer

Sendx Medical Inc

2 recalls in our database name Sendx Medical Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2012-11-14

Of the 2 recalls from Sendx Medical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-0195-2013·2012-11-14

    Sendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error

    Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.

    Product
    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2304-2012·2012-09-05

    Sendx Medical Recalls ABL80 FLEX Blood Gas Analyzers for Glucose Errors

    Sendx Medical Inc is recalling ABL80 FLEX and ABL80 FLEX CO-OX analyzers because glucose measurements may be inaccurate and not reflect patient clinical conditions.

    Product
    ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gase
    Category
    Medical Device
    Distribution
    Distributed nationwide