Recall Z-1734-2011 ยท IDP Microtome, Cryostat
Thermo Fisher Scientific
Thermo Scientific HM 550 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
| Date | Mar 21, 2011 (initiated Sep 23, 2010) |
| Status | Terminated |
| Reason | Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy. |
| Root cause | Device Design |
| Action | ThermoFisher sent Advisory Notice letters beginning on September 28, 2010, to all affected customers. The letters stated that the firm needed to conduct more comprehensive system validation data on the Cold-Disinfection sytem option available on the HM550-D cryostat to support the claim of complete bacterial, fungal and viral disinfection efficacy. The letter recommended that the Cold Disinfection option on the HM550-D not be used as the sole disinfection method on the HM550-D until the validation work is completed. The firm provided addtional safety protocols pertaining to the cryostat dis |
| Quantity | 100 units |
| Distribution | Worldwide Distribution - USA including the states of LA, OH, FL, MD, PA, TX, MO, WI, KS, AL, CA, VA, MS, IL, NE, MA, and the countries of Australia, Belgium, China, Czech Republic, Denmark, Estonia, Finnland, France, Germany, Hong Kong, India, Italy, Japan, Netherlands, Norway, Poland, Portugal, Rus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.