Z-0259-2025Class II

Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin...

Name: Z-0259-2025 Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin...
Creator: Princeton Biomeditech Corp
Published: 2024-08-23
License: https://open.fda.gov/license/

Princeton BioMeditech Corp. / initiated 2024-08-23 / Open, Classified

FDA source

Princeton Biomeditech Corp began a recall of Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of... on 2024-08-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0259-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-23
Posted: 2024-10-30
Recalling firm: Princeton BioMeditech Corp.
Product: Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: 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.
FDA root cause: Process change control
Action: PBM notified the Distributor Sekisui Diagnostics on 8/23/24 via email. The sent an "URGENT PRODUCT RECALL NOTICE" dated 8/30/24 to customers. Sekisui Diagnostics issued a recall notice on 9/6/24 to its customers. PBM Letter states reason for recall, health risk and action to take: Stop distribution or use of OSOM Ultra hCG Combo Test lot 563L13. " If you have further distributed this product, please identify your customers, and notify them at once of this product recall. This recall should be carried out to the user level. Your notification to your customers may be enhanced by including a copy of this recall notification letter. " Quarantine and return any kits from the listed lots, (1) currently in your inventory, and (2) returned from your customers. " Indicate the quantity returned on the attached CONFIRMATION OF NOTIFICATION form, and follow the instructions to complete, even if you do not have any affected product remaining in your inventory. Complete, sign and return the CONFIRMATION OF NOTIFICATION form to the email provided by the date indicated on the form. Please note replacement product equivalent to the quantity of products you returned from the affected lot will be processed once the CONFIRMATION OF NOTIFICATION form has been received. If you have any questions, call PBM Technical Services at Tel 1-732-274-1000 or E-mail .
Quantity in commerce: 1,860 kits (50,220 test devices)
Distribution: US Distribution to MO only.
Product codes and lots: UDI-DI: 00742860100208 Lot Number: 563L13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0259-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0259-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

Product code JHI

K944426Class IIBiosign, Accusign, Lifesign, Hcg Serum/urinePrinceton BioMeditech Corp. / cleared 1994-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)