Recall Z-2656-2017— JAS Diagnostics Inc.

Name: FDA recall Z-2656-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-21

Class II · Terminated

Class II FDA medical device recall by JAS Diagnostics Inc., initiated 2017-04-21, terminated 2020-01-06. It names one FDA 510(k) clearance: K071562. Product: Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.. Reason: May result in elevated platelet backgrounds during routine startup/background checks..

Recalling firm: JAS Diagnostics Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-21
Terminated: 2020-01-06
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 DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

Reason for recall

May result in elevated platelet backgrounds during routine startup/background checks.

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