Z-1641-2022Class II

T-Spot.tb Ref Tb.300 US

Name: Z-1641-2022 T-Spot.tb Ref Tb.300 US
Creator: Oxford Immunotec Ltd
Published: 2022-07-07
License: https://open.fda.gov/license/

Oxford Immunotec Ltd / initiated 2022-07-07 / Open, Classified / root cause: manufacturing process

FDA source

OXFORD IMMUNOTEC LTD began a recall of T-SPOT.TB REF TB.300 US on 2022-07-07. FDA classified it as Class II and gives the reason as "Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1641-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-07
Posted: 2022-08-26
Recalling firm: Oxford Immunotec Ltd
Product: T-Spot.tb Ref Tb.300 US
Product code: OJN Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
Reason for recall: Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
Root cause tag: manufacturing process
FDA root cause: Storage
Action: On 07/07/2022, Oxford Immunotec Limited send a Field Safety Notice to customers informing them that the firm has become aware that products distributed may have been stored outside of the storage specifications for a short period. Customer are asked to quarantined the affected products until further notice. On 07/13/2022, the firm communicated a follow-up "URGENT ACTION REQUIRED" Letter to customer asking to confirm that affected products have been segregated into a quarantine area and have not been used to produce patient results. On 07/20/2022, the firm sent a "VOLUNTARY PRODUCT RECALL NOTIFICATION" informing customers that Oxford Immunotec Limited is conducting a full recall of the affected products and asking customers to now destroy the affected products following these steps: 1. Ensure Recalled Product remains in Quarantine. As per our previous communication dated July-13-2022, please ensure all stock of the above products remain in a secure location pending destruction. 2. Complete Tracking/Verification Form. Complete and return the enclosed tracking/verification form, following the directions on this page and the Tracking/Verification Form. Your Oxford Immunotec sales representative can assist you in completing the form. 3. Indicate Destroyed Products on Tracking/Verification Form. The tracking/verification form lists the [product name] and product descriptions. Please mark the number of each type of [product] that you are destroying on this form. On or after 08/03/2022, Oxford Immunotec Ltd communicated an updated/follow-up customer notification with included the potential risks/harms/hazards associated with the use of the affected products. For questions or assistance - contact Chris Dark at +44 1235 442780 or Maureen Garner at 855-NWRS-222 (855-697-7222), or alternatively any Oxford Immunotec Sales Representatives.
Quantity in commerce: 81 units
Distribution: U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Product codes and lots: Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1641-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1641-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26
Z-1642-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26
Z-1643-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26

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)