Recall Z-2756-2017
PerkinElmer Health Sciences, Inc. · initiated May 31, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: lot numbers 317113 and 317114
Reason for recall
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.
FDA-determined cause: Packaging
Action taken
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 inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.
Details
- Recall number
- Z-2756-2017
- Initiated
- May 31, 2017
- Posted by FDA
- July 24, 2017
- Terminated
- July 27, 2017
- Product code
- PJC – Newborn Screening Specimen Collection Paper
- Quantity
- 99,968 units
- Distribution
- US Distribution to the state of : AL
- Recalling firm
- PerkinElmer Health Sciences, Inc., Greenville, SC