Recall Z-0969-2010 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Becton Dickinson & Co.
BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.
| Date | Mar 3, 2010 (initiated Sep 18, 2009) |
| Status | Terminated |
| Reason | Product was shipped beyond its expiration date. |
| Root cause | Employee error |
| 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. |
| Quantity | 242 packs |
| Distribution | The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.