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.
FDA Recall Z-2756-2017 · Posted 2017-07-24
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Recalling FirmPerkinElmer Health Sciences, Inc.
Recall StatusTerminated
Product CodePJC
Date Initiated2017-05-31
Date Terminated2017-07-27
Product Quantity99,968 units
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.
Firm 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 inventory to PerkinElmer for inspection , and rework if required.
For further questions please call (864) 299-8787.
Root Cause
Packaging
Distribution Pattern
US Distribution to the state of : AL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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