Bio-Rad Labroatories Inc. BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD
Brand
Bio-Rad Labroatories Inc.
Lot Codes / Batch Numbers
Cat. No. 665-1460A containing APF CD SW2_v1.
Products Sold
Cat. No. 665-1460A containing APF CD SW2_v1.
Bio-Rad Labroatories Inc. is recalling BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains due to Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)
Recommended Action
Per FDA guidance
The recalling firm notified consignees by phone call on 9/25/2007, followed up with a fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call. Consignees are instructed to destroy the APF CD which will be replaced at a later date.
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