Recall Z-1576-2016 ยท GKZ Counter, Differential Cell
Jas Diagnostics/Drew Scientific
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
| Date | Mar 10, 2016 |
| Status | Terminated |
| Reason | The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check. |
| Root cause | Process control |
| Action | JAS Diagnostics/ Drew Scientifics sent an Important Product Advisory letter dated March 10, 2016, to all affected customers. The domestic customers were notified via letter and international customers were notified via email. Customers were instructed to contact Drew Scientific Inc. Customer Service or Technical Service at 1-800-433-0945 for product replacement. The firm suggested a temporary workaround of performing five background runs three times per day in order to ensure background counts are running within specification. |
| Quantity | 7,691 |
| Distribution | Worldwide Distribution - US Distribution including the states of : AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, and TX. and to the countries of : Bolivia, Cairo, Columbia, Ecuador, Italy, Moscow, Netherlands, Pakistan, Peru, Slovenia, Spain, and Venezuela. |
| 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 |