Recall record at a glance
| Official record | Z-0728-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Perkinelmer Life Sciences, Inc. |
| Report date | Mar 7, 2018 |
| Recall initiation date | Aug 2, 2017 |
| Quantity | 7 |
| Location | Boston, MA, United States |
Official product description
JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.
Why the product was recalled
We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were failing production final acceptance testing due to a Horizontal Motion Error message displayed on the system. Further investigation concluded that two printed circuit boards (PCB) used in MDT models of Janus and Janus G3 were manufactured with the incorrect resistor values. This anomaly affects component part number 7101640 (PCB-Quad Motor Controller MDT) and part number 7101647 (PCB-Quad Motor Controller Gripper). This anomaly could result in the Horizontal Motion Error being displayed and result in instrument down time. Until PerkinElmer s corrective measures are completed, we request you; ¿ Be aware that there is potential for the Horizontal Motion Error message to display which could result in instrument down time. ¿ Follow guidance provided in the Janus Automated Workstation User Manual when the Horizontal Motion Error message displays. ¿ If you have additional questions, contact PerkinElmer Technical Support for further assistance (800) 762-4000.
Distribution information
Nationwide
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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