Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.
FDA Recall Z-0376-2007 · Posted 2007-01-25
Advertisement
Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeJIT
Date Initiated2006-11-17
Date Terminated2007-11-28
Product Quantity900 kits, 43 sets distributed.
Reason for Recall
The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
Firm Action
The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.
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.
Advertisement