[22072588]
Slides are dirty and full of broken glass particles that obscure the performance of microscopic analysis. Dust and glass particles appear as artifacts during microscopic analysis of specimens. The edges are serrated which causes the slides to be unsuitable in the preparation of differential smears in the hematology dept. Investigation findings: the med material report indicates that this item (model/catalog no 71515 does not meet the spec or the requirements for co's lab testing and is not equivalent to the item in the federal logistics catalog. Subject item was not procured by the depot sys but per the centralized sys. A review of the spec indicates the dimensions are 75 millimeters length and 25 millimeters width [with a + / -(plus/minus) tolerance of 0. 8 millimeters for each dimension]. The thickness range is 0. 8 to 1. 1 millimeters. A review of the federal logistics catalog found: overall thickness range 0. 8 millimeters minimum and 1. 1 millimeters maximum was correctly listed. The dimensions for overall length and overall width should be listed as: overall length 75. 0 millimeters (minimum 74. 2 millimeters and maximum 75. 8 millimeters), and overall width 25. 0 millimeters (minimum 24. 2 millimeters and maximum 25. 8 millimeters). Instead of listed as: overall length 75. 4 millimeters nominal, overall width 25. 0 millimeters nominal. Rptr may have been provided the wrong item if the item rec'd was not in accordance within the dimensions as indicated in the spec. Depot is considering subject complaint an isolated incident. Depot has rec'd no other quality complaints on subject firm. The complaint has been added to depot's quality history data file. Depot will monitor subject firm and if similar complaints are rec'd depot will initiate an investigation. Action taken to correct existing deficiency: an informational copy of the complaint was forwarded to the firm. Action taken to preclude recurrence: the fda was provided an informational copy of the complaint. Disposition instructions: to be locally determined. (retain material until advised. Need for alert notification: not applicable.
Patient Sequence No: 1, Text Type: D, B5