Recall Z-2656-2017 · GKZ Counter, Differential Cell
JAS Diagnostics Inc.
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
| Date | Apr 21, 2017 |
| Status | Terminated |
| Reason | May result in elevated platelet backgrounds during routine startup/background checks. |
| Root cause | Material/Component Contamination |
| Action | The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement. |
| Quantity | 14,064 |
| Distribution | AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia, Republic of C¿te dIvoire, Colombia, Costa Rica, Ecuador, Egypt, Indonesia, Iraq, Italy, Korea, Mexico, Russia, Philippines, Slovenia, Tunisia, Venezuela, and Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071562 | D3 HEMATOLOGY ANALYZER, MODEL D3 Drew Scientific, Inc., Dec 11, 2007 |