Recall record at a glance
| Official record | Z-2881-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Trividia Health |
| Report date | Oct 5, 2016 |
| Recall initiation date | Jun 28, 2016 |
| Quantity | 5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally |
| Location | Fort Lauderdale, FL, United States |
Official product description
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.
Why the product was recalled
Product gives incorrect low blood glucose levels.
Distribution information
Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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