FDA Medical Device Recalls (openFDA)
Thermo Fisher Scientific (Monterrey): 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.
- Recall number
- Z-2126-2020
- Recalling firm
- Thermo Fisher Scientific (Monterrey)
- 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.
- Status
- Terminated
- Initiated
- 2020-04-29
- Posted
- not on file
- Terminated
- 2020-12-10
- Reason
- Product was not irradiated; therefore, they are not sterile and do not meet product specification.
- Root cause
- Material/Component Contamination
- Action
- Thermo Fisher Scientific issued U"RGENT: MEDICAL DEVICE RECALL NOTIFICATION" dated 4/28/20 to First level and second level consignees via email as well as a recall notification letter sent by overnight mail on 4/29/20. Letter states reason for recall, health risk and action to take: Actions Requested: "Examine your inventory to determine if you have any of the above referenced product on-hand. If so, discontinue use immediately and quarantine all affected product. "Notify all affected users in your facility and anyone else you may have distributed or forwarded affected product for the specific lot number. "Please complete the attached Customer Response Sheet, regardless of whether you have affected product on-hand. Indicate the quantity you are returning and whether you are requesting a credit or product replacement and email to technicalsupport@thermofisher.com If you have any questions, call or email Technical Support, at: +1-800-625-4327 or technicalsupport@thermofisher.com
- Quantity
- 78,600 each (786 cartons, 100 devices/carton)
- Distribution
- US Distribution to states of: IL, KY , TX
- Lot, serial or model codes
- Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMH
- Firm FEI
- 3007730738
- Firm city
- Apodaca
- Firm state
- Nuevo Leon
- Firm country
- Mexico
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28