Reported Aug 26, 2015 · Terminated
Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen…
Cepheid
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189
Is this the product you have?
- Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50
- MicrobiologyXpert 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 symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay
- Lot codes and dates
- Part numberGXCT/NGURINE-50
- Lot numbers23E104B, 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
- Amount recalled
- 1800 kits US, 31 ROW
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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