Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
Biocare Medical
10 recalls • • Categories: Infusion Pumps, Surgical Instruments, Other Medical Devices, Diagnostic Equipment
Class I - Dangerous
Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations.
Class I - Dangerous
Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Class I - Dangerous
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer.
Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.