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Terminated

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.

FDA Recall Z-1584-2016 · Posted None

Recalling FirmRESEARCH INSTRUMENTS LTD - SITE B
Recall StatusTerminated
Product CodeMQJ
Date Initiated2016-03-11
Date Terminated2021-03-02
Product Quantity380 units

Reason for Recall

The units have been fitted with a potentially faulty power supply cable.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003142MICROMANIPULATORResearch Instruments , Ltd. · 2000-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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