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Osom Ultra hCG Combo Test- IVD immunoassay for the… recallZ-0259-2025 · Princeton Biomeditech Corp · initiated Aug 23, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Princeton Biomeditech Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Process change control

What the company is doing

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 .

Recall details

Recall number
Z-0259-2025
Status
Open, Classified
Initiated by the company
Aug 23, 2024
Posted by the FDA
Oct 30, 2024
Recalling firm
Princeton Biomeditech Corp
Quantity
1,860 kits (50,220 test devices)
Product code
JHI
FDA submissions
K944426
Distribution
US Distribution to MO only.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00742860100208 Lot Number: 563L13

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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