The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites a

FDA device recall Z-1961-2015 · posted 2015-07-02 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

D50 and D51 Diagnostic error codes are not functional.

Action taken

Siemens sent an Urgent Field Safety Notice April 2015, to all affected customers. Customers were notified of the recall beginning on May 6, 2015 via Federal Express. Foreign customers were notified starting on May 5, 2015 via method determined by each countries local regulations and procedures. The notification informs customers of the issue and asks customers to do the following: Ensure that the Glucose and Lactate sensor contacts are aligned and completely seated with the contacts on the analyzer, Analyze a minimum of 2 levels of quality control material after installing the sensors, as indicated in the RAPIDLab 1200 Operator's Guide, Review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 7 days. Retain this letter with your laboratory records, and forward this letter to those who may have received this product. For further questions please call (800) 242-3233.

Root cause

Software design

Status

Terminated

Product code

CGA

Quantity affected

122 devices

Distribution

Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia

Date initiated

2015-05-06

Date posted

2015-07-02

Date terminated

2017-08-02

Location

East Walpole, MA

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