Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | 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 gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting. |
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| Recall Number | Z-2304-2012 |
| Classification | Class II |
| Code Info | Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers |
| Product Distributed Qty | ABL80 FLEX is 1680, ABL80 CO-OX is 1759 |
| Reason For Recall | The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition. |
Event Detail
| Event Id | 60514 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Sendx Medical Inc |
| City | Carlsbad |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-06 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution - US Nationwide including the state of OH. |
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