Cepheid Recalls Xpert CT/NG Vaginal and Endocervical Specimen Collection Kits
Cepheid is recalling Xpert CT/NG Vaginal/Endocervical Specimen Collection Kits because some lots contain a sub-component with an earlier expiration date than the kit itself.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates that use of the product is not likely to cause adverse health consequences. The issue is a documentation/expiration date discrepancy rather than a direct safety hazard like contamination or structural failure.
Plain-English summary
Cepheid is recalling specific lots of the Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit (Part number CT/NGSWAB-50). The recall involves 729 kits in the United States and 47 kits in other regions. The affected lots include 46A202C, 46A202D, 46A202E, 46A202F, 46A202G, 26N121H, and 28N134D.
The firm determined that some lots of the collection kits contain a sub-component with an expiration date that is earlier than the expiration date of the kit itself. This discrepancy could potentially affect the integrity of the specimen collection process.
The affected products were distributed worldwide, including in the United States, Canada, and various countries in Europe, South America, Africa, and Asia. Consumers and healthcare providers should stop using the affected kits and contact Cepheid for further instructions.
The recalled product
- Product
- Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DN
- Manufacturer
- Cepheid
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Part number: CT/NGSWAB-50: Lot numbers: 46A202C
- 46A202D
- 46A202E
- 46A202F
- 46A202G
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cepheid under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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