PerkinElmer RoboRack Filter Tips Recalled for Inaccurate Liquid Handling
PerkinElmer is recalling 595 trays of RoboRack filter tips because they may not seal properly, causing inaccurate liquid aspiration and dispensing in automated workstations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves inaccurate liquid handling which could impact clinical sample preparation, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
PerkinElmer, Inc. is recalling 595 trays (571,200 tips) of RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized (Item Number: 6000689). These tips are supplied for use with JANUS Automated Workstations and the NGS Express, which are automated, programmable liquid handling instruments intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows.
The recall was initiated because the filter tips were molded incorrectly and may not seal to the Varispan tip adaptor properly. This defect can cause inaccurate aspiration and dispensing of liquids. The affected lot numbers are 15470394, 15471775, 1601067, and 16071147.
The products were distributed worldwide, including in the United States (CA, MA, NY, IA, OR, PA, WA) and internationally to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and the UK. Users should stop using the affected tips and contact PerkinElmer for instructions on return or replacement.
The recalled product
- Product
- Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01…
- Manufacturer
- PerkinElmer, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers:15470394
- 15471775
- 1601067
- 16071147
Distribution
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