TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters
Medical device recall Z-2880-2016. Published in FDA’s Enforcement Report on Oct 5, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 5, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 47 states named
- 5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Product gives incorrect low blood glucose levels.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Strip Lot #: PS2265 PS2283 PS2285 PS2281 PS2278 PS2276 PS2275 PS2215 PS2271 PS2279 PS2209 PS2299 PS2273 PS2274 PS2280 PS2219 PS2277 PS2268 PS2282 PS2296 PS2288 PS2284 PS2291 PS2287 PS2286 PS2297 PS2252 PS2293 PS2302 PS2292 PS2313 PS2270…
Every code shown here, 1,996 characters
Strip Lot #: PS2265 PS2283 PS2285 PS2281 PS2278 PS2276 PS2275 PS2215 PS2271 PS2279 PS2209 PS2299 PS2273 PS2274 PS2280 PS2219 PS2277 PS2268 PS2282 PS2296 PS2288 PS2284 PS2291 PS2287 PS2286 PS2297 PS2252 PS2293 PS2302 PS2292 PS2313 PS2270 PS2190 PS2189 PS2290 PS2298 PS2303 PS2289 PS2294 PS2295 PS2300 PS2304 PS2325 PS2312 PS2311 PS2305 PS2306 PS2315 PS2301 PS2314 PS2310 PS2347 PS2309 PS2318 PS2395 PS2320 PS2321 PS2316 PS2317 PS2330 PS2327 PS2324 PS2323 PS2333 PS2326 PS2328 PS2334 PS2329 PS2331 PS2332 PS2336 PS2335 PS2340 PS2345 PS2308 PS2341 PS2339 PS2307 PS2343 PS2353 PS2352 PS2338 PS2348 PS2342 PS2355 PS2344 PS2359 PS2362 PS2357 PS2349 PS2376 PS2356 PS2350 PS2367 PS2351 PS2346 PS2354 PS2371 PS2360 PS2366 PS2364 PS2370 PS2355SER PS2363 PS2319 PS2365 PS2361 PS2368 PS2372 PS2381 PS2369 PS2377 PS2392 PS2380 PS2374 PS2375 PS2373 PS2378 PS2379 PS2382 PS2380SER PS2383 PS2389 PR2068 PS2393 PS2384 PS2400 PS2391 PS2401 PS2402 PS2408 PS2388 PS2386 PS2387 PS2390 PS2385 PS2399 PS2396 PS2406 PS2398 PS2409 PS2337 PS2397 PS2404 PS2403 PS2322 PS2412 PS2416 PS2417 PS2419 PS2418 PS2420 PS2405 PS2413 PS2414 PS2394 PS2411 PS2415 PS2421 PS2267INT PS2336ILA PS2190IGB PS2267IGB PR2122INT PS2189INT PS2319INT PS2252ILA PS2345INT PS2279ILA PS2319IGB PS2407IGB PS2322IGB PS2349ITT PS2394ILA PS2307ILA PS2309ILA PS2308ILA PS2415INT PS2351ILA PS2337ILA PS2415ILA PS2411ILA PS2384ILA PS2394INT PS2413ILA PR2156INT PS2284ICA PS2316ICA PS2335ICA RS4646 RS4631 RS4649 RS4645 RS4652 RS4641 RS4653 RS4638 RS4612 RS4644 RS4655 RS4669 RS4567 RS4639 RS4605 RS4659 RS4654 RS4657 RS4608 RS4660 RS4662 RS4634 RS4676 RS4670 RS4665 RS4544 RS4674 RS4607 RS4688 RS4673 RS4667 RS4678 RS4680 RS4686 RS4677 RS4679 RS4695 RS4699 RS4703 RS4689 RS4704 RS4692 RS4694 RS4698 RS4663 RS4705 RS4708 RS4719 RS4710 RS4715 RS4717 RS4714 RS4723 RR4521 RS4716 RS4724 RS4645IGB RS4567ICA RS4704ICA DR4559 DS4648 DS4624 DS4658 DS4579 DS4672 DR4559IBR DR4559INT DS4624INT DS4648IBR DS4658INT DS4658IBR DS4624IBR DS4579IBR DS4711INT DS4672INT…
FDA’s list runs to 4,793 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
47 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 28, 2016.
- FDA classified it on Sep 23, 2016.
- FDA’s Enforcement Report published it on Oct 5, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Trividia Health, of Fort Lauderdale, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,793 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.