Osom Ultra hCG Combo Test- IVD immunoassay for the recall
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early…
Why was Osom Ultra hCG Combo Test- IVD immunoassay for the 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00742860100208 Lot Number: 563L13
- Product
- Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early…
- Recalling firm
- Princeton Biomeditech Corp
- Quantity
- 1,860 kits (50,220 test devices)
- Distribution
- US Distribution to MO only.
- Recall date
- November 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)