Z-2126-2020Class II

Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen...

Name: Z-2126-2020 Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen...
Creator: Thermo Fisher Scientific (Monterrey)
Published: 2020-04-29
License: https://open.fda.gov/license/

Thermo Fisher Scientific (Monterrey) / initiated 2020-04-29 / Terminated / root cause: manufacturing process

FDA source

Thermo Fisher Scientific (Monterrey) began a recall of Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection... on 2020-04-29. FDA classified it as Class II and gives the reason as "Product was not irradiated; therefore, they are not sterile and do not meet product specification". 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-2126-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-29
Posted: 2020-05-26
Terminated: 2020-12-10
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.
Product code: FMH Container, Specimen, Sterile
Reason for recall: Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Root cause tag: manufacturing process
FDA 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 [email protected] If you have any questions, call or email Technical Support, at: +1-800-625-4327 or [email protected]
Quantity in commerce: 78,600 each (786 cartons, 100 devices/carton)
Distribution: US Distribution to states of: IL, KY , TX
Product codes and lots: Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2126-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2126-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code FMH

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)