Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001.
FDA device recall Z-0528-2009 · posted 2009-01-15 · Terminated
Recall details
- Recalling firm
- Mainline Technology, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- not available
- Distribution
- Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
- Date initiated
- 2008-08-18
- Date posted
- 2009-01-15
- Date terminated
- 2011-02-07
- Location
- Ann Arbor, MI
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