Class 2 Device Recall Osom Ultra hCG Combo Test

• Date Initiated by Firm: August 23, 2024
• Date Posted: October 30, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0259-2025
• Recall Event ID: 95439
• 510(K)Number: K944426
• Product Classification: Visual, pregnancy hCG, prescription use - Product Code JHI
• 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
• Code Information: UDI-DI: 00742860100208 Lot Number: 563L13
• Recalling Firm/ Manufacturer: Princeton Biomeditech Corp; 4242 US Highway 1; Monmouth Junction NJ 08852-1905
• For Additional Information Contact: SAME; 732-274-1000
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JHI