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Terminated

f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.

FDA Recall Z-0530-2009 · Posted 2009-01-15

Recalling FirmMainline Technology, Inc.
Recall StatusTerminated
Product CodeJHI
Date Initiated2008-08-18
Date Terminated2011-02-07
Product Quantity52 kits

Reason for Recall

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.

Firm Action

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.

Root Cause

PMA

Distribution Pattern

Worldwide Distribution --- including USA and countries of Belgium and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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