Z-2976-2020Class III

Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 -

Name: Z-2976-2020 Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 -
Creator: Oxford Immunotec
Published: 2020-07-16
License: https://open.fda.gov/license/

Oxford Immunotec Ltd / initiated 2020-07-16 / Terminated / root cause: labeling and UDI

FDA source

Oxford Immunotec began a recall of Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis... on 2020-07-16. FDA classified it as Class III and gives the reason as "Incorrect expiration date included in test kit labeling and/or in Substrate component label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2976-2020
Classification: Class III
Status: Terminated
Initiated: 2020-07-16
Posted: 2020-09-16
Terminated: 2021-09-13
Recalling firm: Oxford Immunotec Ltd
Product: Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
Product code: OJN Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
Reason for recall: Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The recall letters were sent to consignees on July 16, 2020 and sent via certified mail (return receipt). Actions to be taken by the Customer/User: Locate the product in possession, and any in central supply departments, and note the quantity remaining on the verification form attached to this notification. Return the completed form following the instructions below. Then collection of the remaining product will be arranged and shipment of the replacement product. If there has been further distribution of the affected lot number also forward the notification to the appropriate end users. NOTE: NO OTHER LOTS OR PRODUCTS ARE INVOLVED IN THIS RECALL.. There is an enclosed verification form to acknowledge that the recall notice has been received and to document the quantity remaining in stock for return and replacement. Complete the form immediately indicating one of the following options: - There is no remaining stock of the aforementioned kit lots. - There is stock of the aforementioned kit lots remaining in inventory. Record the quantity of stock remaining for replacement. The verification form should be sent via email to Ben Hamilton at [email protected], even if there is no product remaining in inventory. The completed form should also be returned using a prepaid enclosed envelope . Upon receipt of the completed and returned verification form, there will be contact to arrange courier collection of any remaining stock, and be provided information as to when replacement stock will be shipped. Other Information: For questions regarding this voluntary recall notification, or would like assistance with this recall, call: - Ben Hamilton at +44 1235 442619, Monday through Friday, 8 am to 12 pm Eastern Time - Alternatively, call the toll-free number at 1-877-208-7768, Monday through Friday, 8 am to 12 pm Eastern Time. Following the automated instructions, dial 4 to go through to the name directory and request Ben Hamilton. If no one is available t
Quantity in commerce: 583 units
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Product codes and lots: Manufacturing Kit Lot Numbers: TEC3321847, TEC3041811.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2976-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2976-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-16
Z-2977-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-16

Product code OJN

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)