VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Reported: July 1, 2015 Initiated: May 19, 2015 #Z-1841-2015
Product Description
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Reason for Recall
Use of the recalled product may result in false positive reports.
Details
- Recalling Firm
- Remel Inc
- Units Affected
- 143 devices
- Distribution
- Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.. Recalled by Remel Inc. Units affected: 143 devices.
Why was this product recalled? ▼
Use of the recalled product may result in false positive reports.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1841-2015.
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