Recall Z-0259-2025 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Princeton Biomeditech Corp
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
| Date | Oct 30, 2024 (initiated Aug 23, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| 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 co |
| Quantity | 1,860 kits (50,220 test devices) |
| Distribution | US Distribution to MO only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944426 | BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE Princeton BioMeditech Corp., Oct 25, 1994 |