CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Samco Bio-Tite Sterile Specimen Container/, Bio-Tite Blue Cap recalled
Thermo Fisher Scientific (Monterrey) is recalling Samco Bio-Tite Sterile Specimen Container/, Bio-Tite Blue Cap, distributed in Illinois, Kentucky, Texas. The recall was initiated on 29 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2126-2020
- FDA event ID
- 85561
- Recalling firm
- Thermo Fisher Scientific (Monterrey), Apodaca Nuevo Leon 66600, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2020
- FDA classified
- 26 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 29 Apr 2020 | Recall initiated by company | |
| 26 May 2020 | Classified by FDA | +27 days |
| 3 Jun 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of: IL, KY , TX
Questions about this recall
Why was it recalled?
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Which lots are affected?
Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4
Where was it sold?
US Distribution to states of: IL, KY , TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Thermo Fisher Scientific (Monterrey)
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|---|---|---|---|---|---|
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| Device | CLASS II | Cardinal Health Brand/ sterile recalled by Thermo Fisher ScientificCardinal Health | Thermo Fisher Scientific (Monterrey) | Foreign Material | OH |
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