FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1576-2016
- Recalling firm
- Jas Diagnostics/Drew Scientific
- Product
- Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
- Status
- Terminated
- Initiated
- 2016-03-10
- Posted
- not on file
- Terminated
- 2019-08-21
- 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.
- Lot, serial or model codes
- Lot # 0825, exp 01/06/2018; Lot # 0826, exp 01/06/2018; Lot # 0827, exp 01/06/2018; Lot # 0828, exp 01/21/2018; Lot # 0829, exp 01/21/2018; Lot # 0830, exp 01/21/2018; Lot # 0831, exp 01/21/2018; and Lot # 0832, exp 01/21/2018.
- 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