Recall Z-0312-2017 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
| Date | Jun 1, 2016 |
| Status | Terminated |
| Reason | BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes. |
| Root cause | Process control |
| Action | All US customers were contacted via letters sent via UPS. Ex-US BD sites will contact customers in their local regions. The firm will use an acknowledgement form included with the follow up letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement |
| Quantity | 94 |
| Distribution | BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers. US: AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI. Ex-US: Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023301 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM Becton, Dickinson & CO, Nov 12, 2002 |