Food, drugs, devices › JAS Diagnostics Inc.
Device recall: Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA enforcement event 68343 is a device recall by JAS Diagnostics Inc. of Miami Lakes, FL, initiated 7 Apr 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 Aug 2014. Initiation: voluntary: firm initiated. JAS Diagnostics Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
JAS Diagnostics Inc., Miami Lakes, FL.
Reason for recall
"JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1873-2014 | Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. | 407 | Class II | Terminated | 2 Jul 2014 |
Context
Other enforcement events for JAS Diagnostics Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Apr 2017 | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. | Device | Class II | 1 |
| 23 Oct 2014 | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum. | Device | Class II | 1 |
All 3 events for JAS Diagnostics Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.