[Recalled] T-SPOT.TB REF TB.300 US — Due to equipment failure, affected products were stored at temperatures outside… | FDA 2022-07-07
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | T-SPOT.TB REF TB.300 US |
|---|---|
| Brand / manufacturer | OXFORD IMMUNOTEC LTD |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1641-2022 |
| Country of notice | United Kingdom |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 07 July 2022 |
| EAN / barcode | 15051716000305 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.