FDAClass IIMay 11, 2016

Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with recall

Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD…

Why was Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with recalled?

Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Software Versions: Version 1.6.1 and 1.6.2

Product
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD…
Recalling firm
Ab Sciex
Quantity
279
Distribution
Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM
Recall date
May 11, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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