Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
FDA Recall Z-1868-2019 · Posted None
Recalling FirmThermo Fisher Scientific (Asheville) LLC
Recall StatusTerminated
Product CodeJTQ
Date Initiated2019-04-02
Date Terminated2020-07-23
Product Quantity12 units
Reason for Recall
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Firm Action
Thermo Fisher issued on 4/02/19 via Email notification with attachments to distributors (domestic and foreign) the Urgent Medical Recall Notification Letter with customer response sheet. Recall is to the user level.On May 23, 2019 email followed by a formal written, "Urgent Medical Device Recall Notification
Letter" with customer response sheet were sent via US mail to domestic customers.
Letters address health risk and action to take: customer service team is prepared to send you a replacement immediately and the necessary materials and instructions for the return of the bath you received initially to the factory. Please call representatives with your original purchase order, company name, and contact information at 866-984-3766 or email the included Recall Customer Response Form.
Root Cause
Process control
Distribution Pattern
CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.