FDASeptember 10, 2020device
Instructions For Use document of the GPS Trackers.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
What to do
FDA enforcement status: Terminated
Brands named
blue orthoblue
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCBlue Wave Recalls Above-Ground Pools 48 Inches and Taller Due to Drowning Hazard2025-12-18
- FDABlue Oven Artisan Bakery English Muffins, Net Wt. 13.4 oz (380g), packaged as a 4-pack in a clear plastic bag, UPC 1987156843222025-10-30
- FDAChocolate Chip Cookie Dough ice cream cartons with a Moo-llennium Crunch lid. Packaging contains Moo-llennium crunch. Packaged in half gallon cartons (1.89 L)2025-08-21
- FDAChemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.2025-07-29
- FDAVITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.2025-07-29
- FDAVITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;2025-07-09
- FDAVITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.2025-06-12
- FDABrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/...2025-06-10
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