FDAJune 22, 2016device
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAMi More snacks, Coco Bandera, 3 oz. Plastic container, 8 per container, 20 per case box2024-12-04
- USDA FSISFSIS Issues Public Health Alert for Raw Pork Chorizo Products Due to Possible Foreign Matter Contamination2024-05-02
- FDA3-ounce H-E-B Creamy Creations Ice Cream Homemade/Chocolate Combo -12 pack2024-04-27
- FDA3-ounce H-E-B Creamy Creations Chocolate Ice Cream-12 pk2024-04-27
- FDA3-ounce H-E-B Creamy Creations Ice Cream Lime/Orange Combo - 12 pack2024-04-27
- FDAAbbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 551702024-03-01
- FDAREF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 22922023-06-09
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