BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Reported: October 14, 2020 Initiated: August 31, 2020 #Z-0085-2021
Product Description
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Reason for Recall
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 2623 (US); 3735 (ex-US)
- Distribution
- Nationwide Foreign: Canada, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Algeria, Argentina, Aruba, Australia, Bahrain, Bosnia-Herz., Brazil, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Malaysia, Martinque, Mexico, Monaco, Morocco, Namibia, New Caledonia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russia, Saudi Arabia, Singapore, S. Africa, S. Korea, Taiwan, Thailand, Ukraine, UAE, Vietnam
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 2623 (US); 3735 (ex-US).
Why was this product recalled? ▼
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0085-2021.
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