Z-1868-2019Class II

Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10

Name: Z-1868-2019 Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
Creator: Thermo Fisher Scientific (Asheville) LLC
Published: 2019-04-02
License: https://open.fda.gov/license/

Thermo Fisher Scientific (Asheville) LLC / initiated 2019-04-02 / Terminated / root cause: manufacturing process

FDA source

Thermo Fisher Scientific (Asheville) LLC began a recall of Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10 on 2019-04-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1868-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-02
Posted: 2019-06-21
Terminated: 2020-07-23
Recalling firm: Thermo Fisher Scientific (Asheville) LLC
Product: Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
Product code: JTQ Bath, Incubators/Water, All
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 12 units
Distribution: CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
Product codes and lots: Serial Numbers: 300246811 300246812 300246814 300246815 300247403 300247404 300247406 300247407 300247409 300247789 300247791 300247792

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1865-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1866-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1867-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1868-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1869-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1870-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1871-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1872-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1873-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21

Product code JTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)