BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 66
FDA device recall Z-1159-2008 · posted 2008-06-11 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories
- Reason for recall
- False negative results due to reagent packs exhibiting low signal.
- Action taken
- On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LKJ
- Quantity affected
- 8,804 kits
- Distribution
- Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
- Date initiated
- 2007-11-13
- Date posted
- 2008-06-11
- Date terminated
- 2011-05-23
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K043341) | Bio-Rad Laboratories, Inc. | 2005-10-27 |