Mainline Technology, Inc. f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.
Brand
Mainline Technology, Inc.
Lot Codes / Batch Numbers
Lot 20087.
Products Sold
Lot 20087.
Mainline Technology, Inc. is recalling f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065. due to Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.
Recommended Action
Per FDA guidance
Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026