Inverness Medical BioStar Inc. BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
Brand
Inverness Medical BioStar Inc.
Lot Codes / Batch Numbers
Lot # 193130DA Lot trace: 193198, 193198-2, 193199, 193199-2, 194062, 194062-2.
Products Sold
Lot # 193130DA Lot trace: 193198, 193198-2, 193199, 193199-2, 194062, 194062-2.
Inverness Medical BioStar Inc. is recalling BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027 due to Diagnostic kits for flu were distributed with incorrect components.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Diagnostic kits for flu were distributed with incorrect components.
Recommended Action
Per FDA guidance
Consignees were notified by a Important Customer Notification letter on 7/2/2008 and told to re-examine patient records that indicated a negative result and to destroy any remaining recalled product. The accompanying record should be filled out and faxed to Technical Service. If consignees further distributed any kits, they were to forward the notification to these accounts to assure that patient results were reviewed, and destruction of remaining kits could be verified. For assistance, customers can call 800-637-3717.
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