FDA Enforcement
Class II
Terminated
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
Recall: Z-0689-2013
·
Reported January 23, 2013
Enforcement
- Recall Number
- Z-0689-2013
- Event ID
- 63771
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Perkinelmer
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 23, 2013
- Initiation Date
- November 26, 2012
- Classification Date
- January 16, 2013
- Termination Date
- March 7, 2014
- Address
- 940 Winter Street, N/A, Waltham, MA, 02451, United States
Description
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
Reason
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Code Info
Lot Numbers: 618609
Distribution
Nationwide Distribution.
Quantity
56 kits (100 plates/kit)