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U.S. Department of Health and Human Services

Class 2 Device Recall TRUEtest Blood Glucose Test Strips (GDHPQQ)

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  Class 2 Device Recall TRUEtest Blood Glucose Test Strips (GDHPQQ) see related information
Date Initiated by Firm June 28, 2016
Create Date September 23, 2016
Recall Status1 Open3, Classified
Recall Number Z-2880-2016
Recall Event ID 74805
510(K)Number K080641  K080710  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product 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.
Code Information 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 BS4643 BS4640 BS4650 BS4668 BS4661 BS4588 BS4651 BS4621 BS4664 BS4615 BS4675 BS4666 BS4629 BS4687 BS4681 BS4696 BS4700 BS4707 BS4693 BS4671 BS4690 BS4697 BS4701 BS4706 BS4709 BS4713 BS4720 BS4682 BS4683 BS4721 BS4643INT BS4588INT BS4697INT BS4651INT BS4629INT BS4682IAT BS4629IAT BS4602INT BS4666INT BS4682INT BS4603INT BS4671IAT. Kit Lot #: KS0967 KS1022 KS1214 KS1312 KS1154 KS1688 KS1631 KS1301 ks1133 KS1341 KS1063 KS1109 KS0968 ks1449 KS1340 KS1032 KS1266 KS1714 KS1910 KS1473 KS1546 KS1524 KS1759 KS1152 ks1108 KS1153 KS1243 KS1790 KS1763 KS1132 KS1306 KS0981 ks1323 KS1175 KS1909 KS1426 KS1215 KS1687 KS1533 KS1300 KS1643 KS1360 KS1779 KS1671 KS1933 KS1943 KS1597 KS1020 KS1417 KS1488 KS1730 KS1732 KS1496 KS1650 KS1469 KS2235 KS1501 KS1736 KS1531 KS1107 KS1580 KS1021 KS1267 KS1051 KS1646 KS1483 KS1363 KS1925 KS1659 KS0994 KS1028 KS1369 KS1627 KS1049 KS1389 KS1701 KS1053 KS1048 KS1444 KS1176 KS1364 KS0980 KS1147 KS1797 KS1957 KS1459 KS1497 KS1767 KS1311 S1700 S1700 KS1474 KS1276 KS1532 KS1792 KS1542 KS1366 KS1339 KS0988 KS1268 KS1445 ks1045 KS1447 KS1362 KS1545 KS1725 KS1692 ks1434 KS2217 KS1543 KS1031 KS1047 KS1295 KS2260 KS1764 KS1189 KS1726 KS1510 KS1278 KS2415 KS1258 KS1748 KS0996 KS1734 KS1121 KS1724 KS1187 KS1574 KS1422 KS2324 KS1365 KS1023 KS1594 KS1525 KS2373 KS1303 KS1448 KS2449 KS1534 ks1188 ks1443 KS1661 KS1930 KS2437 KS1230 KS0970ITH KS1423 KS1999ITH KS1418ITH KS1134ITH KS1229 KS1228 KS0818 KS1030ITH KS1419ITH KS1241 KS1941 KS1796 KS1954 KS1190 KS1281 KS1559 KS1489 KS1737 KS1927 KS1326 KS1560 KS1528 KS1000 KS1162 KS1453 KS1942 KS0993 KS1145 KS1944 KS1751 KS1320 KS0995 KS1441 KS1747 KS1277 KS1052 KS1599 KS1752 KS1217 KS1731 KS1013 KS1302 KS1553 KS1928 KS1186 KS1395 KS1144 KS1544 KS1487 KS1697 KS1940 KS1762 KS2414 KS1465 KS1917 KS2417 KS1468 KS1143 KS1089 KS2418 KS1116 KS1500 KS1006 KS1535 KS1704 KS1071 KS1288 KS1626 KS1628 KS2323 KS1070 KS1115 KS1446 KS0992 KS1573 KS0999 KS1705 KS1750 KS1221 KS1127 KS1567 KS1527 KS1557 KS2453 KS2971 KS1406 KS1680 KS1682 KS1056 KS1057 KS1679 KS1681 KS1684TI KS1683TI KS1786TI KS1298TI KS1042TI KS1526TI KS1988TI KS1297TI KS1787TI KS1036TI KS1041TI KS1604TI KS1177TI KS1432TI KS1603TI KS2051TI KS1135TI KS1130TI KS0921TIIBD KS1699TIIBD KS1347TI KS1348TI KS0910TI KS1346TI. Prepackaged Lot #: KS1236 KS0889 KS1670 KS1932 KS1456 KS1709 KS1250 KS1329 KS0896 KS1578 KS0948 KS1387 KS1648 ks1667 KS1736 KS1914 KS0900 KS1067 KS1665 KS0899 KS1076 KS1916 KS0946 KS1201 KS1582 KS1794 KS1197 KS1330 KS1294 KS0986 KS1309 KS1505 KS0975 KS1477 KS1262 KS1079 KS1458 KS1630 KS0891 KS1174 KS1203 KS1506 KS1663 KS1744 KS0850 KS1452TI KS1018TI KS1635TI KS1138TI KS0933TI KS1165TI KS1352TI KS1521TI KS1540TI KS1508TI KS1912TI KS1260TI KS1008TI KS0837TI KS1248TI KS1055TI KS1746TI KS1234TI KS1247TI KS0984TI KS1233TI KS1139TI KS1149TI KS1148TI. 
Recalling Firm/
Manufacturer
Trividia Health
2400 NW 55th Ct
Fort Lauderdale FL 33309-2672
For Additional Information Contact Lisa Nardi
800-342-7226 Ext. 2183
Manufacturer Reason
for Recall
Product gives incorrect low blood glucose levels.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Trividia, issued a press release on 06/28/2016 that instructed users to locate the test strip lot number on product on hand in order to determine if they possess affected product. Customers were instructed to contact Stericycle at 1-888-835-2723 or check online at www.trividiahealth.com/product-notice to see if their inventory was affected by the recall. Any strips under recall will be returned for disposal and replaced with no charge. In addition, the firm sent an "Urgent Medical Device Voluntary Recall" notice to customers addressing the recall and steps to follow. The customers were instructed to identify affected product using the same method: contacting Stericycle at 1-888-835-2723 or checking www.trividiahealth.com/product-notice to see if the product in possession was from affected lots; to notify patients that they may continue use of TRUEread, TRUEtrack, TRUEbalance, and TRUEtest strips not under recall, and to use them with the appropriate meter. Pharmacists/DME providers were instructed to call Stericycle if health care professionals contacted them regarding the recall. Distributors were requested to check their meter and strip inventories to see if they had any affected lots. Distributors were instructed to notify their own customers of the recall and collect product that is affected by the recall. Once all affected product is received by customers, distributors need to call Stericycle to obtain prepaid return labels. All returned product will be replaced at no charge. If you have any questions, contact Vice President of Marketing, at (800) 342-7226 ext. 2183 or email: LNardi@trividiahealth.com.
Quantity in Commerce 5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = HOME DIAGNOSTICS, INC.
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