Recalls / —
—#87682
Product
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 product code
- MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot 7016132, Exp date 01/17/09.
Why it was recalled
Product was shipped beyond its expiration date.
Root cause (FDA determination)
Employee error
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Co.
- Address
- 7 Loveton Cir, Sparks, Maryland 21152-9212
Distribution
- Distribution pattern
- The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia.
Timeline
- Recall initiated
- 2009-09-18
- Posted by FDA
- 2010-03-03
- Terminated
- 2010-03-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #87682. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.