FDAClass IISeptember 26, 2012

Instrumentation Laboratory ACL TOP 700 PN 0000280010 recall

Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in…

Why was Instrumentation Laboratory ACL TOP 700 PN 0000280010 recalled?

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

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?

Serial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012

Product
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in…
Recalling firm
Instrumentation Laboratory Co.
Quantity
304 units
Distribution
Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.
Recall date
September 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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