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PRINCETON BIOMEDITECH CORP.

United States·US-MF-000048310

Last updated September 17, 2026

Information

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Accusign Bzo, Biosign Bzo, Status Bzo	K991079	FDA 510(k)	Class II	Active
Accusign Doa 10, Accusign Doa Panel, Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp, Biosign Doa 10, Biosign Met/Opi/Coc/	K983501	FDA 510(k)	Class II	Active
Biosign, Accusign, Lifesign, Hcg Serum/Urine	K944426	FDA 510(k)	Class II	Active
Accusign Doa 3/Doa 3 (bzo/Bar/Pcp), Bzo/Bar/Pcp, Biosign Doa 3/Bzo/Bar/Pcp, Biosign Bzo/Bar/Pcp	K961325	FDA 510(k)	Class II	Active
BioSign Flu A+B	K182157	FDA 510(k)	Class II	Active
Accusign Met/Biosign Met	K961249	FDA 510(k)	Class II	Active
Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik Coc	K014069	FDA 510(k)	Class II	Active
Biosign Hcg I - One Step Pregnancy Test	K981443	FDA 510(k)	Class II	Active
Accusign Doa 3, Accusign Doa, Accusign Bar/Bzo/Mtd, Biosign Doa 3, Biosign Bar/Bzo/Mtd	K961010	FDA 510(k)	Class II	Active
Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp, Biosign Doa10, Biosign Met/Opi/	K990786	FDA 510(k)	Class II	Active
Modification To Cardiac Status Ck-Mb/Myoglobin Rapid One-Step Test, Lifesign Mi Ck-Mb/Myoglobin, Lifesign Ck-Mb/Myoglobi	K991299	FDA 510(k)	Class II	Active
Cardiac Status Ck-Mb/Myoglobin/Troponin I Rapid Test	K981882	FDA 510(k)	Class II	Active
BioSign hCG	BSP-121-35	EUDAMEDFDA UDI	IVD General	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 23, 2024	Z-0259-2025	—	open, classified	This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.
Mar 9, 2012	Z-2306-2012	—	terminated	There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Mar 9, 2012	Z-2307-2012	—	terminated	There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Mar 9, 2012	Z-2308-2012	—	terminated	There have been reports of dual positive (Flu A + Flu B positive) results being encountered.