Food, drugs, devices › JAS Diagnostics Inc.
Device recall: Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA enforcement event 77464 is a device recall by JAS Diagnostics Inc. of Miami Lakes, FL, initiated 21 Apr 2017 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 6 Jan 2020. 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
"May result in elevated platelet backgrounds during routine startup/background checks."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2656-2017 | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. | 14,064 | Class II | Terminated | 12 Jul 2017 |
Context
Other enforcement events for JAS Diagnostics Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Oct 2014 | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum. | Device | Class II | 1 |
| 7 Apr 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: "May result in elevated platelet backgrounds during routine startup/background checks."
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: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Jan 2020. "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.