Recall Z-2121-2011 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC
| Date | Apr 29, 2011 (initiated Oct 20, 2010) |
| Status | Terminated |
| Reason | RETIC results may be invalid when the instrument user interface allows reflex processing of a pre-diluted specimen in the RETIC test panel. Beckman Coulter has validated pre-diluted specimen processing in CBC panels. RETIC test panel using pre-diluted samples has not been validated. IMPACT: The reticulocyte value is an indicator for assessing red cell production. Erroneous results could impact c |
| Root cause | Other |
| Action | The firm, Beckman Coulter, issued an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010, with PCA Response Form to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Remove all cassettes from the mix station prior to initiating the Diluent Dispense function. Do not initiate Diluent Dispense while specimens are being processed in cassette presentation. 2)Do not use pre-diluted samples for RETIC counts. The instrument is v |
| Quantity | 422 units in total (175 in US) |
| Distribution | Worldwide distribution: USA (nationwide) and countries including:Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081930 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Dec 19, 2008 |