China’s medicines regulator recalled 2.6 million glucose-test strips on 8 October after clinics reported readings that did not match repeat tests. A Plausible Post investigation found that public purchasing records and the recall’s batch codes point to stock from a production line the manufacturer had listed as suspended months earlier.
The strips, made by Nanyu Health Instruments, were sold in 11 provinces and supplied to at least 63 public hospitals, according to procurement notices. The recall covers 183,000 boxes with an estimated wholesale value of ¥38 million (about €4.8 million); officials have not confirmed any serious harm linked to their use.
Batch codes point to a closed line
The recall notice cites unstable enzyme coating, which can produce inaccurate readings, but does not mention a production-line shutdown. A technical filing posted by the company in March said its L-2 coating line had stopped operating after humidity-control failures. The recalled batch codes include “L2” and dates from April to June, according to the notice’s annex.
Nanyu operations director Ghenadie Cornea said the code referred to a product family, not a particular machine. “Those batches passed the checks required before release, and the recall is a precaution while we review the complaints,” he said. The company has not provided production logs that would settle whether L-2 made the recalled stock.
A laboratory at a Guangzhou medical college tested 48 unopened strips from two recalled batches at the newspaper’s request. Eleven readings differed from a reference value by more than 15%, the margin used in common performance standards for these devices. Biomedical engineer Naresh Shetty, who supervised the test, said the result justified a wider examination, but did not establish how often users received inaccurate readings.
“A batch label is not a factory floor, but these readings are too far out to dismiss as noise,” Shetty said. The test was not an official regulator assessment; the samples came from a pharmacy and the lab did not assess strips from other production dates.
Public procurement notices show 63 hospitals bought at least 410,000 strips between May and September. Three hospital pharmacies in Guangdong said they had stopped issuing the product after the recall; two had already logged patient complaints about readings that changed sharply on immediate retesting. The regulator has not published a total of complaints or a breakdown by province.
Clinics rush to replace stock
At a public outpatient pharmacy in Guangzhou, staff were separating recalled boxes from other supplies on Wednesday and offering patients replacement strips from a different brand. Victoria Thamrin, who helps patients compare glucose-monitor readings at a local support group, said several people had paid out of pocket for replacements while waiting for clinics to replenish stock.
The recall notice tells users to stop using the listed batches and return them to sellers. No deaths or serious injuries have been linked to the strips in the regulator’s public tally. But hospital staff interviewed by the newspaper said the notice gave them no direct way to check which patients had used the affected batches, and no estimate of when replacement supplies would arrive.
Cornea said Nanyu had paused shipments, offered refunds and sent inspectors to check its production rooms. The regulator said it was tracing distribution and testing retained samples; it has not said whether the company’s other products are under review. The agency is expected to publish a follow-up notice once the batch checks are complete.
