Company: Precision Piece Parts IncProduct:. Ilio-sacral bone screws Date: 12/15/2004 You failed to validate the original and subsequent changes to computer software used to control automated production and quality system operations, as required by 21 CFR 820.70(i). [See, for example, FDA483 observations 18 and 19.]. FDA District: Detroit District OfficeRead More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: III PRODUCT CXP software for Cytomics FC500 Cytometer. Recall # Z-0266-05. REASON Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect. CODE Versions 1.0, 1.1, and 2.0. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter of...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: II PRODUCT Access Immunoassay Systems, Discrete photometric chemistry analyzer. Recall # Z-0265-05. REASON A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: II PRODUCT DL2000 Data Manager Software, Version 6.4.108. Recall # Z-0267-05. REASON Possibility of reporting an incorrect result occurs due to a software anomally. CODE Version 6.4.108. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on November 5, 2004. Firm initiated recall is ongoing. VOLUME...Read More