Cepheid Recalls Xpert CT/NG Urine Specimen Collection Kits
Cepheid is recalling Xpert CT/NG Urine Specimen Collection Kits because some lots contain a sub-component with an expiration date earlier than the kit's expiration date.
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 the product is not likely to cause adverse health consequences. The issue is a documentation and expiration date discrepancy rather than a direct safety hazard like contamination or malfunction.
Plain-English summary
Cepheid is recalling specific lots of the Xpert CT/NG Urine Specimen Collection Kit, part number GXCT/NGURINE-50. The recall involves 1,800 kits in the United States and 31 kits in other regions. The affected lots include 23E104B, 23E104C, 26N128C, 26N1281, 29N142A, 29N142B, 29N142C, 29N142D, 29N142E, 29N142F, and 29N142G. These kits feature transfer pipettes expiring in May, June, or July 2016, and collection kits expiring in August, September, October, or November 2016.
The recall was initiated because the firm determined that some lots contain a sub-component with an expiration date that is earlier than the overall kit expiration date. This discrepancy could affect the reliability of the specimen preservation and transport process for Chlamydia trachomatis and Neisseria gonorrhoeae DNA.
The affected products were distributed worldwide, including in the United States, Canada, and various countries in Europe, South America, Africa, and the Pacific. Users of these kits should check their lot numbers and expiration dates against the list provided by Cepheid. If the kits match the recalled lots, users should stop using them and contact Cepheid for instructions on replacement or return.
The recalled product
- Product
- Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptom
- Manufacturer
- Cepheid
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 (15)
- Part number: GXCT/NGURINE-50
- Lot numbers: 23E104B
- 23E104C
- 26N128C
- 26N1281
- 29N142A
- 29N142B
- 29N142C
- 29N142D
- 29N142E
- 29N142F
- and 29N142G All with transfer pipette expiring end of May
- June or July 2016. Collection kits expires in August
- September
- October of November 2016.
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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