FDA Medical Device Recalls (openFDA)
JAS Diagnostics Inc.: Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
- Recall number
- Z-1873-2014
- Recalling firm
- JAS Diagnostics Inc.
- Product
- Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
- Status
- Terminated
- Initiated
- 2014-04-07
- Posted
- 2014-06-25
- Terminated
- 2014-08-21
- Reason
- JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.
- Root cause
- Mixed-up of materials/components
- Action
- JAS Diagnostics, Inc. sent an Important Product Recall Information letter dated April 7, 2014 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1) Screen their inventory for any of the lots listed in the letter and discontinue use immediately. 2) Contact the Customer Service Department at 305-748-2762 or 305-748-2763 to obtain replacement product.
- Quantity
- 407
- Distribution
- Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.
- Lot, serial or model codes
- LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.
- 510(k) numbers
- ["K011900"]
- PMA numbers
- not on file
- Product code
- CGA
- 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