Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum
Summary
The FDA issued a Class II for Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of huma by Princeton Biomeditech Corp. 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.
Details
Source
Device Recall
External ID
Z-0259-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 00742860100208 Lot Number: 563L13
Quantity Affected: 1,860 kits (50,220 test devices)
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.
Distribution
US Distribution to MO only.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-23
Company
Monmouth Junction, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Princeton Biomeditech Corp has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Princeton Biomeditech Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Princeton Biomeditech Corp have FDA actions?
Princeton Biomeditech Corp has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0259-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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