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Terminated

The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.

FDA Recall Z-0801-2013 · Posted 2013-02-11

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJSK
Date Initiated2012-10-10
Date Terminated2013-06-04
Product Quantity10 units

Reason for Recall

The product may contain low level microbial contamination which could result in incorrect results.

Firm Action

ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization. The firm request the information form be faxed back confirming receipt of notice. For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144.

Root Cause

Material/Component Contamination

Distribution Pattern

Distribution included the states of IL, IN and MI.

Official Source

View FDA Recall →

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

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