FDAJuly 16, 2020device
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - 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-gamm...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
What to do
FDA enforcement status: Terminated
Brands named
oxford immunotecoxford
UPCs
1505171600004
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAIM-V Medium REF AV.200/5002022-07-07
- FDAT-SPOT.TB REF TB.300 US2022-07-07
- FDAT-Cell Xtend REF TTK.610 US2022-07-07
- FDABusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-102021-05-05
- FDAModel 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-gamm...2020-07-16
- FDASmall White Button Mushroom Regular Batter: ATLANTIC GOLD Battered Mushrooms Net Weight 5 lb (2.27 kg) - 34086; Atlantic Gold Battered Mushrooms 6 x 2 lbs 12 lbs - 34112;2017-06-07
- FDAThin Cut Regular Batter: BLUE ACRES BATTERED ONION RINGS, NET WT. 10 lb (4.54 kg) - 33049; ATLANTIC GOLD BATTERED ONION RINGS NET WT. 4/2.5 lb (1.13 kg) 10 lb (4.54 kg) - 33219; ATLANTIC GOLD Regular Battered Onion Rings 4-40oz (2.5 lb) 1.13kg Packages (Net Weight 10 lb (4.54kg)) - 33205; RED LIO...2017-06-07
- FDAALE HOUSE BEER BATTERED 3/8 ONION RINGS - NET WT. 4/2.5 lb (1.13 kg) 10 lb (4.54 kg) - 332212017-06-07
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