Cepheid

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

Product testing did not meet expected stability criteria.

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

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.

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.

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.

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.

Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.