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Terminated

BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.

FDA Recall Z-0969-2010 · Posted 2010-03-03

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeMKZ
Date Initiated2009-09-18
Date Terminated2010-03-24
Product Quantity242 packs

Reason for Recall

Product was shipped beyond its expiration date.

Firm Action

The recalling firm notified end users by letter flagged as "Urgent Product Recall" on 09/18/09. The notification advised that the referenced lot number had been correctly labeled with expiration date but had been shipped after the labeled date. End users were instructed to discontinue use discard product for replacement and return enclosed response form. If further assistance is needed regarding replacements, please contact SD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact SD Technical Services Department at 1-800-638-8663.

Root Cause

Employee error

Distribution Pattern

The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia.

Official Source

View FDA Recall →

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

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