Recall Z-1584-2016 ยท MQJ Micromanipulators And Microinjectors, Assisted Reproduction
RESEARCH INSTRUMENTS LTD - SITE B
Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
| Date | Mar 11, 2016 |
| Status | Terminated |
| Reason | The units have been fitted with a potentially faulty power supply cable. |
| Root cause | Device Design |
| Action | Research Instruments sent a recall notification dated 03/11/2016, via UPS with confirmed delivery receipt, to all affected customers. The letter identified the affected product, problem and the action needed to be taken by the customer. The letter asked customers to contact Research Instruments First Line Support if they had any questions. |
| Quantity | 380 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003142 | MICROMANIPULATOR Research Instruments , Ltd., Nov 22, 2000 |