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Terminated

The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.

FDA Recall Z-1962-2015 · Posted 2015-07-02

Recall StatusTerminated
Product CodeCGA
Date Initiated2015-05-06
Date Terminated2017-08-02
Product Quantity2713 devices

Reason for Recall

D50 and D51 diagnostic error codes are not functional.

Firm Action

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

Distribution Pattern

Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Bosnia, Herzog,Brazil, Brunei, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany,Georgia, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Venezuela and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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