Thermo Fisher Recalls Non-Sterile Bio-Tite Specimen Containers
Thermo Fisher Scientific is recalling 78,600 Bio-Tite specimen containers that were not irradiated and are not sterile.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility in a medical device used for specimen collection, which poses a risk of harm without reported injuries.
Plain-English summary
Thermo Fisher Scientific is recalling 78,600 units of Samco Bio-Tite Sterile Specimen Containers, 120mL/53mm, with Bio-Tite Blue Caps (Catalog Number: 07 0006). The affected units are from Lot # 1270428, with an expiration date of November 19, 2021. These containers are used for the temporary collection, transfer, and storage of body fluids and solid specimen samples for laboratory testing.
The recall was initiated because the product was not irradiated. As a result, the containers are not sterile and do not meet the required product specifications. The affected units were distributed in the United States to the states of Illinois, Kentucky, and Texas.
Healthcare facilities and laboratories should stop using the affected containers and contact Thermo Fisher Scientific for further instructions. Consumers should not use these products for medical or laboratory purposes.
The recalled product
- 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.
- Manufacturer
- Thermo Fisher Scientific (Monterrey)
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 (2)
- Lot# 1270428
- Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4
Distribution
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