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Terminated

PerkinElmer 226 Sample Collection Device

FDA Recall Z-2264-2020 · Posted None

Recalling FirmPerkinElmer Health Sciences, Inc.
Recall StatusTerminated
Product CodePJC
Date Initiated2017-12-19
Date Terminated2021-03-26
Product Quantity164,952 devices

Reason for Recall

PerkinElmer 226 Sample Collection Devices Lot Number 40020001 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 12/22/2017 by email to the sole consignee. PerkinElmer requested the consignee quarantine the product and contact Kerry Chunko, PerkinElmer Sr. Quality Manager for further information 864-299-8787. x 104 ([email protected]). The firm also requested the consignee inform all those affected by this issue in their organization and to return the recall response form and return it by fax to 864-299-8787 or as a scanned by email to [email protected].

Root Cause

Packaging process control

Distribution Pattern

US distribution in the state of Ohio

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121864PERKINELMER 226 SAMPLE COLLECTION DEVICESPerkinelmer, Inc. · 2013-03-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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