Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-CTR.
FDA Recall Z-0527-2009 · Posted 2009-01-15
Recalling FirmMainline Technology, Inc.
Recall StatusTerminated
Product CodeJHI
Date Initiated2008-08-18
Date Terminated2011-02-07
Product Quantitynot available
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.