Device recall: DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine
FDA enforcement event 65980 is a device recall by Assuramed of Twinsburg, OH, initiated 16 Jul 2013 and classified Class II, with 3 product records.
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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 27 Dec 2017. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Assuramed.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Assuramed, Twinsburg, OH.
Reason for recall
"The products may have been stored at temperatures outside their required storage conditions."
Distribution
"Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2196-2013 | DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid… | 10 units | Class II | Terminated | 25 Sep 2013 |
| Z-2197-2013 | Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator… | 13 units | Class II | Terminated | 25 Sep 2013 |
| Z-2198-2013 | ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only);… | 1) 72 units; 2) 56 units | Class II | Terminated | 25 Sep 2013 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The products may have been stored at temperatures outside their required storage conditions."
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: "Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Dec 2017. "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.