NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determinat
FDA device recall Z-0688-2013 · posted 2013-01-16 · Terminated
Recall details
- Recalling firm
- Perkinelmer
- Reason for recall
- Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
- Action taken
- Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: - Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use. - If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing. - If a hole or crack is not visually detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation. Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JLA
- Quantity affected
- 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-11-26
- Date posted
- 2013-01-16
- Date terminated
- 2014-03-07
- Location
- Waltham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B (K071649) | Wallac OY | 2008-08-07 |