NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for
FDA device recall Z-0686-2013 · 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
- JNB
- Quantity affected
- 180 kits (20 plates/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
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (K021541) | Perkinelmer Life Sciences | 2002-10-28 |