Agency classClass IIIOur severity:Low FDA (Devices)·Z-2431-2015·Announced 2015-08-26

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.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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…
Manufacturer: Cepheid
Category: Medical Device — Diagnostic Collection Kit
Hazard: mis-labeling

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 2 products in this recall →

Same manufacturer · Cepheid

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