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Recall of warfarin test strips has been expanded

On Behalf of | May 10, 2019 | Medication Errors

Last November, Roche Diagnostics recalled over a million packages of test strips used with the CoaguCheck Test Meter, which measures the level of the blood thinner warfarin. The strips were determined to be faulty, which could result in inaccurate readings.

Warfarin users must monitor their levels because their medication dosage is dependent on the level of warfarin already in their system. An inaccurate test strip reading could lead to an improper dosage, which could cause serious harm – even death.

In February, Terrific Care/Medex Supply issued a voluntary recall for more of the same test strips. These strips were sold outside – and not authorized for use in – the United States, and were therefore not included in the original recall.

According to the FDA, the strips were purchased by Terrific Care/Medex Supply from an unknown source, then imported and sold in the U.S. These strips may be sold via Amazon, eBay, Craigslist, etc. Warfarin users should also never use pre-owned test strips.

The test strips that were recalled in November 2018 were distributed from January until October of 2018 and are listed below. Anyone using the CoaguCheck should check their lot number against them. The lot number is printed on the test strip label which can be found on the test strip box and the test strip vial.

  • Name and Version: CoaguChek XS PT Test Strips
  • Lot numbers: 28124111, 28124121, 28631911, 28631921, 28631924, 28632021, 28632213, 28632312, 28632412, 29415113, 29415123, 29494221, 29494312, 29494613, 29494711, 29778721, 29779012, 29779213, 29779214, 30497213, 30497311, 30497413, 30497423, 30497515, 31404314, 31404821, 32264116, 32264212, 32264316, 32264317, 32264411, 32264421, 33045913, 33046011, 33046113, 33046312, 33046314, 33046321, 33046322, 33449612, 33449712, 33449723, 33449817
  • Models: CoaguChek XS PT Test 2×24 Strips, CoaguChek XS PT Test 6 Strips, CoaguChek XS Test 24 Tests USA


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