The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for iso

FDA device recall Z-0801-2013 · posted 2013-02-11 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

JSK

Quantity affected

10 units

Distribution

Distribution included the states of IL, IN and MI.

Date initiated

2012-10-10

Date posted

2013-02-11

Date terminated

2013-06-04

Location

Lenexa, KS