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
FDA Recall Z-0256-2008 · Posted 2007-11-09
Recalling FirmBio-Rad Labroatories Inc.
Recall StatusTerminated
Product CodeLIP
Date Initiated2007-09-25
Date Terminated2008-04-16
Product Quantity36
Reason for Recall
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)
Firm Action
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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.