FDAJune 22, 2016device
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
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
alere san diegoalerealere san
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCDemlar Recalls MoonSoll and Magic Chems Fuel Bottles Due to Risk of Serious Injury or Death from Flash Fire; Violates Mandatory Standard for Portable Fuel Containers and FHSA Labeling Requirements; Imported by Demlar Online Store2025-11-20
- 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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