Recall Z-0397-2011 ยท MVU Reagents, Specific, Analyte
BD Biosciences, Systems & Reagents
BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).
| Date | Dec 2, 2010 (initiated Nov 23, 2009) |
| Status | Terminated |
| Reason | Incorrect expiration date: product with an expiration date of 03/31/2010 was marked with an incorrect expiration date of 06/30/2010. |
| Root cause | Labeling mix-ups |
| Action | A Product Field Action Notification letter, dated November 2009, was sent to customers who purchased the affected device. The letter identified the affected device and explained the reason for recall. Customers were asked to not use the current CD45 APC H-7 lot number 58633 past 2010-03-31 until they receive their new lot of CD45 APC H-7 at no cost to them. Customers were also asked to complete and return the attached fax form. Questions should be directed to BD Customer Support Center at 1-877-232-8995. |
| Quantity | 87 units |
| Distribution | Nationwide Distribution -- CA, WA, NJ, UT, TX and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.