Mainline Technology, Inc. Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.
Brand
Mainline Technology, Inc.
Lot Codes / Batch Numbers
Cat. # 3030-20: Lots 94355, 94385, 94395, 94415, 94445, 94455, 94485, 94505, 94545, 94585, and 94595. Cat. # 3030-40: Lots 94350, 94370, 94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590, 94610, 94620, 94630, and 94880.
Products Sold
Cat. # 3030-20: Lots 94355, 94385, 94395, 94415, 94445, 94455, 94485, 94505, 94545, 94585, and 94595. Cat. # 3030-40: Lots 94350, 94370, 94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590, 94610, 94620, 94630, and 94880.
Mainline Technology, Inc. is recalling Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026