Recall Z-2126-2020— Thermo Fisher Scientific (Monterrey)
Class II · Terminated
Class II FDA medical device recall by Thermo Fisher Scientific (Monterrey), initiated 2020-04-29, terminated 2020-12-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.. Reason: Product was not irradiated; therefore, they are not sterile and do not meet product specification..
- Recalling firm
- Thermo Fisher Scientific (Monterrey)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-29
- Terminated
- 2020-12-10
- Firm location
- Apodaca Nuevo Leon 66600, N/A, Mexico
Product description
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
Reason for recall
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.