FDA Medical Device Recalls (openFDA)
JAS Diagnostics Inc.: Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
- Recall number
- Z-2656-2017
- Recalling firm
- JAS Diagnostics Inc.
- Product
- Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
- Status
- Terminated
- Initiated
- 2017-04-21
- Posted
- not on file
- Terminated
- 2020-01-06
- 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
- Lot, serial or model codes
- Lot # 0868 Exp. Date 11/28/2018, Lot # 0869 & Lot 0870 Exp. Date 01/10/2019, Lot # 0871,0872, 0873, 0874 , 0875, and 0876 Exp. Date 02/06/2019, and Lot # 0877, 0877, 0879, 0880, 0881, and 0882 Exp. Date 02/23/2019
- 510(k) numbers
- ["K071562"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 3003071743
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28