Recall Z-1956-2011 ยท GKL Counter, Cell, Automated (Particle Counter)
Beckman Coulter Inc.
Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis.
| Date | Apr 12, 2011 (initiated Jan 31, 2011) |
| Status | Terminated |
| Reason | This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS if the year is greater than 2010. The following dates are affected: Run date, Control expiration date, Date of birth (For individuals born in 2011 or later), a |
| Root cause | Software design |
| Action | The firm, Beckman Coulter, sent an "URGENT: PRODUCTION CORRECTION" letter dated January 31, 2011 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Coulter LH 750 Analyzer, Coulter LH 780 Analyzer, Coulter LH 500 Series System, and Coulter GEN S System. The letter describes the product, problem and actions to be taken. The customers were instructed to work with their US vendor to assess how this affects their laboratory. The actions they choose are dependent on the configuration of their LIS. ACTION FOR ISSUE 1: Use Sample Drawn Date a |
| Quantity | 9419 (total units distributed in U.S. & foreign countries) |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Algeria, Andorra, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Guadelo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962988 | COULTER GEN-S SYSTEM Coulter Corp., Oct 30, 1996 |