Mainline Technology, Inc. Recalls
Showing 1-3 of 3 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.
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
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 expirations dates.
Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.
Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test).
Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.
Consignees were notified by phone and follow-up letter on or about 11/6/06 advising them of the problem. Consignees were give the option of returning the product and receiving the correct tip, or keeping the product and adding extra drops. Additional written notice was provide to each consignee.