Mainline Technology, Inc. Recalls

Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.

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.

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.