SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated an

FDA device recall Z-1384-2012 · posted 2012-04-09 · Terminated

Recall details

Recalling firm

Sendx Medical Inc

Reason for recall

The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.

Action taken

SenDx Medical sent Customers notification letters dated January 30th, 2012, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. We have recently become aware of a possible condition in a limited number of ABLBO FLEX analyzers configured with a specific Control PCe lerinted Circuit Board), which can cause the analyzer to report values outside the published performance specifications for pH, pCOz, cNa*, cK*, cCa2* and cCl-. Customers were instructed to immediately implement Alternative 1 or 2 until the signal data PCB is replaced. Alterative I: Stop the use of all affected analyzers until corrective actions can be performed on these analyzers. Alternative 2: Verify proper function of the affected analyzers immediately following every patient sample measurement by measuring a manual QC sample. Customers were asked to complete the fax form acknowledging receipt of the notice and provided a contact for Technical Support at 1-800-736-0600 opt.4.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CHL

Quantity affected

819 analyzers and 44 signal data PCBs

Distribution

One US consignee in state of OH. Other consignees are international such as Australia, France, Netherlands, Denmark, China, United Kingdom, Turkey, Switzerland, Japan, India, Poland, Spain, and German

Date initiated

2012-01-30

Date posted

2012-04-09

Date terminated

2012-07-13

Location

Carlsbad, CA

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