Counterfeit Strips and Third-Party Generics

Counterfeit Strips and Third-Party Generics

A strip that isn't in the meter maker's own box can be one of three things. A counterfeit copies a brand's packaging but comes from an unknown factory [1]. A pre-owned strip has passed through a previous owner's hands, and an unauthorized one isn't authorized for sale in the U.S. at all [2]. A third-party strip is made by a different company to fit a brand-name meter, and a few of these have FDA clearance for specific older meters [3] [4]. The FDA's concern with the first two is simple: an inaccurate result used as the basis for treatment can lead to serious injury, including death [2].

What the 2006 counterfeit wave showed

In the fall of 2006, more than one million counterfeit blood glucose test strips were sold to U.S. consumers at drugstores in more than 35 states, and in other countries too [5]. When we searched the FDA's recall database for counterfeit strips filed under the product code for over-the-counter glucose test systems, we found seven records [1]. Every one names LifeScan OneTouch strips (Ultra, or Basic/Profile), and every one was started between October 2006 and February 2007 by a supplier or wholesaler, not by LifeScan itself [1].

Here's what surprised us: two different companies, a Mississippi diabetic supply business and a separate distributor, recalled the same counterfeit lot number, 2691191 [1]. The Mississippi record gives the reason as "Counterfeit-blood glucose test strips (manufacturer unknown)," and the FDA posted it as a Class 1 recall in January 2007 [6]. The lot number is what let the records connect one fake batch across more than one business.

Why the box alone won't tell you

Writing about the 2006 case, Cheng argued that counterfeit medical products can no longer be identified just by checking packaging and labels, because fake packaging has become cheap and easy to produce [5]. Without testing the product itself, the paper says, consumers and authorities find counterfeits nearly impossible to detect. It adds that the pricier a product is, the harder counterfeiters work to copy it [5].

That leaves the supply chain as the main defense. The FDA recommends checking whether a package has been opened or altered, checking the expiration date, and buying from a trusted source such as a local pharmacy or the strip manufacturer [2]. If prescription-only strips can be bought without a prescription, the FDA says they may not be authorized for U.S. sale [2]. For an overview of the packaging side, see our article on smart packaging and anti-counterfeit technologies.

Pre-owned and unauthorized strips

On April 8, 2019, the FDA warned against using test strips from a previous owner, or strips not authorized for sale in the U.S. [2]. It said sellers were offering them through online marketplaces such as Amazon, eBay and Craigslist, or directly. Such strips may be expired or stored improperly, which can produce inaccurate results. They can also carry small amounts of the previous owner's blood, which brings an infection risk [2].

The agency was candid on two points. It said it wasn't aware of deaths or serious injuries tied specifically to pre-owned or unauthorized glucose strips, and it acknowledged that people may buy them because they believe they're saving money [2]. Its advice for anyone who can't afford new strips was to talk with a health care provider or pharmacist, and it noted that some manufacturers offer patient assistance programs, coupons or prescription cards [2].

What FDA clearance means for a third-party strip

Both third-party strips below reached the market through a 510(k), a premarket submission in which the FDA decides whether a device is "substantially equivalent" to a comparison device, called a predicate, that is already sold. For GenStrip, the predicate was the OneTouch Ultra system itself [3]. The FDA's 2020 guidance for over-the-counter glucose systems defines third-party strips as strips made and distributed by a company other than the meter's maker [7]. Because strips and meters "work as integral systems," the guidance says a change to the meter's design could break compatibility, so third-party makers should explain in their 510(k) how they will manage that risk. One option it names is an agreement with the meter manufacturer [7].

The two clearances we read show how narrow that review is:

• GenStrip (Shasta Technologies, K103542, cleared November 30, 2012) covers OneTouch Ultra, Ultra2 and UltraMini meters bought before July 2010 and set to calibration codes 4, 10 or 13 [3]. It uses glucose oxidase, the same enzyme as the OneTouch Ultra strip it was compared against [3].
• UniStrip1 (UniStrip Technologies, K113135, cleared November 6, 2013) covers OneTouch Ultra, Ultra2, UltraMini and UltraSmart meters bought before October 2012 and set to calibration code 49 [4].

Neither decision summary explains the purchase-date cutoffs, and neither says anything about price [3] [4]. What the dates do mean is concrete: a OneTouch Ultra2 meter bought after October 2012 falls outside both clearances [3] [4]. Whether a particular strip fits your meter is a question for your pharmacist or care team. For the legal side of third-party strips, see our article on third-party generic strip litigation.

Which third-party strips the FDA still lists

As of October 2026, the FDA's device identifier database (GUDID) lists UniStrip1 strips, labeled for OneTouch Ultra-family meters bought before October 2012, as in commercial distribution [8]. It also lists three GenUltimate products from Pharma Tech Solutions (GenUltimate!, GenUltimate and GenUltimate Zephyr!) as in commercial distribution, and the GenUltimate and GenUltimate Zephyr! records cite the GenStrip clearance, K103542 [8]. In those records, Pharma Tech Solutions describes its strips as "Value Priced Test Strips." The newest of these records was published in January 2020 [8]. A database listing doesn't prove a product is on a pharmacy shelf, and we didn't check retail stock.

Third-party strips are not the same as store brands

"Generic" also gets used for store brands, which work differently. The ReliOn Premier Classic and ReliOn Premier BLU are complete meter-and-strip systems that the FDA cleared for the manufacturer i-SENS in 2019 and 2023 [9]. Because one company submitted the meter and strips together as a system, they don't fit the FDA's definition of a third-party strip [7], and the meter-change risk the guidance describes isn't the same concern for them.