Recall Z-1576-2016— Jas Diagnostics/Drew Scientific

Name: FDA recall Z-1576-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-10

Class II · Terminated

Class II FDA medical device recall by Jas Diagnostics/Drew Scientific, initiated 2016-03-10, terminated 2019-08-21. It names one FDA 510(k) clearance: K071562. Product: Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.. Reason: The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check..

Recalling firm: Jas Diagnostics/Drew Scientific
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Terminated: 2019-08-21
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K071562 — D3 HEMATOLOGY ANALYZER, MODEL D3Drew Scientific, Inc.·cleared 2007-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

Reason for recall

The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.

Data sourced from openFDA. This site is unofficial and independent of the FDA.