Class I - Dangerous
Product testing did not meet expected stability criteria.
Cepheid
10 recalls • • Categories: Other Medical Devices, Diagnostic Equipment, Infusion Pumps
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
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.