Z-0256-2008

BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the...

Name: Z-0256-2008 BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the...
Creator: Bio-Rad Labroatories Inc.
Published: 2007-09-25
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2007-09-25 / Terminated / root cause: labeling and UDI

FDA source

Bio-Rad Labroatories Inc. began a recall of 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 on 2007-09-25. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0256-2008
Status: Terminated
Initiated: 2007-09-25
Posted: 2007-11-09
Terminated: 2008-04-16
Recalling firm: Bio-Rad Laboratories Inc.
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
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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)
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 36
Distribution: Nationwide
Product codes and lots: Cat. No. 665-1460A containing APF CD SW2_v1.

Product code LIP

K063866Class IIBioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories / cleared 2007-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)