Recall Z-1394-2017 ยท MLA Dna Probe, Yeast
Becton Dickinson & Co.
BD AffirM VPIII Microbial Identification Test
| Date | Feb 27, 2017 (initiated Aug 27, 2015) |
| Status | Terminated |
| Reason | BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert. |
| Root cause | Employee error |
| Action | Becton Dickinson sent an Urgent Product Recall Letter dated August 2015. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. Customers were not asked to send product back. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663. For further questions please call (410) 316-4428. |
| Quantity | Qty Distributed to Field - 4,502 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and t |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931374 | AFFIRM VPIII MICROBIAL IDENTIFICATION TEST Microprobe Corp., Jun 15, 1993 |