Recall Z-2756-2017 ยท PJC Newborn Screening Specimen Collection Paper
PerkinElmer Health Sciences, Inc.
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
| Date | Jul 24, 2017 (initiated May 31, 2017) |
| Status | Terminated |
| Reason | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. |
| Root cause | Packaging |
| Action | PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed |
| Quantity | 99,968 units |
| Distribution | US Distribution to the state of : AL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES Perkinelmer, Inc., Mar 12, 2013 |