Cepheid recalls Xpert Xpress Strep A tests with specific lot numbers due to potential for invalid results from improper sample volume dispensing.
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Cepheid is recalling Xpert Xpress Strep A tests (model XPRSTREPA-10) with certain lot numbers because pipettes in these tests may not dispense enough sample, leading to invalid or no results. This could cause inaccurate strep A testing, which is important for diagnosing strep throat infections.
The pipettes in these tests may fail to dispense an adequate sample volume, which can cause the test to show invalid results or no result. This means the test might not correctly detect strep A bacteria, potentially leading to incorrect diagnoses of strep throat.
Healthcare providers and labs using the recalled Xpert Xpress Strep A tests with specific lot numbers are most at risk of inaccurate test results.
Check the product lot numbers listed in the recall: 23718, 23719, 23720, 10309, 23201, 23305, 23308, 23312, 23314, 23315, 23401, 23402, 23403, 23404, 23405, 23406, 23407, 23501, 23504, 23505, 23506, 23408, 23410, 23510, 23411, 23604, 23605, 23607, 23608, 23609, 23610, 23611, 23612, 23701, 23702, 23703, 23705, 23706, 23707, 23708, 23709, 23710, 23711, 23712, 23714, 23716, 23717, 23113, 23316, 23912, 24112, 23820, 24704, 24302, 24307, 24507, 24508, 24511, 23822, 23823, 23824, 24512, 24513, 24514, 23825, 24313, 24515, 24516, 24517, 24805. The product is a prescription-only diagnostic test for strep A.
Look for the specific lot numbers listed in the recall: 23718, 23719, 23720, 10309, 23201, 23305, 23308, 23312, 23314, 23315, 23401, 23402, 23403, 23404, 23405, 23406, 23407, 23501, 23504, 23505, 23506, 23408, 23410, 23510, 23411, 23604, 23605, 23607, 23608, 23609, 23610, 23611, 23612, 23701, 23702, 23703, 23705, 23706, 23707, 23708, 23709, 23710, 23711, 23712, 23714, 23716, 23717, 23113, 23316, 23912, 24112, 23820, 24704, 24302, 24307, 24507, 24508, 24511, 23822, 23823, 23824, 24512, 24513, 24514, 23825, 24313, 24515, 24516, 24517, 24805.
The product is Cepheid Xpert Xpress Strep A (model XPRSTREPA-10), a prescription-only diagnostic test for strep A.
The affected lot numbers are: 23718, 23719, 23720, 10309, 23201, 23305, 23308, 23312, 23314, 23315, 23401, 23402, 23403, 23404, 23405, 23406, 23407, 23501, 23504, 23505, 23506, 23408, 23410, 23510, 23411, 23604, 23605, 23607, 23608, 23609, 23610, 23611, 23612, 23701, 23702, 23703, 23705, 23706, 23707, 23708, 23709, 23710, 23711, 23712, 23714, 23716, 23717, 23113, 23316, 23912, 24112, 23820, 24704, 24302, 24307, 24507, 24508, 24511, 23822, 23823, 23824, 24512, 24513, 24514, 23825, 24313, 24515, 24516, 24517, 24805.
The pipettes in these tests may fail to dispense an adequate sample volume, which could result in invalid test results or no result.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0215-2024 — Cepheid Cepheid Hello, I own a Cepheid that is covered by recall Z-0215-2024 from Cepheid. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
