Recalls / —
—#114256
Product
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 product code
- JSK — Supplement, Culture Media
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot 1175209
Why it was recalled
The product may contain low level microbial contamination which could result in incorrect results.
Root cause (FDA determination)
Material/Component Contamination
Action the firm took
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.
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- Distribution included the states of IL, IN and MI.
Timeline
- Recall initiated
- 2012-10-10
- Posted by FDA
- 2013-02-11
- Terminated
- 2013-06-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #114256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.