Z-2756-2017 Class III Terminated
FDA device recall Z-2756-2017 was initiated by PerkinElmer Health Sciences, Inc. on May 31, 2017 and is designated Class III. 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. The recall status is terminated (terminated July 27, 2017). Affected quantity: 99,968 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- May 31, 2017
- Termination Date
- July 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99,968 units
Product Description
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.
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.
Distribution Pattern
US Distribution to the state of : AL
Code Information
lot numbers 317113 and 317114