Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: PerkinElmer NeoBase Non-Derivatized Assay Solutions

02 Mar 2015

Medical device manufacturer, PerkinElmer, has issued a medical device safety alert concerning its NeoBase Non-Derivatized Assay Solutions [Product number: 3041-0020; Lot number: 1063599401, 1063599501].

The manufacturer has become aware that some bottles used in the manufacturing of the NeoBase Extraction Solution (lots 634151 and 634247) and NeoBase Flow Solvent (lots 634152 and 634303), contained cardboard lint and red particles. Bottles containing the aforementioned particles were used in the packaging of NeoBase Non-Derivatized Assasy Solutions kit lots 1063599401 and 1063599501. The particles can be visually detected by the human eye.

The manufacturer has become aware that some bottles used in the manufacturing of the NeoBase Extraction Solution (lots 634151 and 634247) and NeoBase Flow Solvent (lots 634152 and 634303), contained cardboard lint and red particles. Bottles containing the aforementioned particles were used in the packaging of NeoBase Non-Derivatized Assasy Solutions kit lots 1063599401 and 1063599501. The particles can be visually detected by the human eye.

According to the manufacturer, the affected products are not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 2 March 2015

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