ClearanceBrief
Recall Z-1979-2011 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc.

COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial Numbers(s): All Serial Numbers The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).

DateApr 14, 2011 (initiated Feb 23, 2011)
StatusTerminated
ReasonThe recall was initiated because Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT and MPV without instrument generated messages, for the first run of a capped patient sample. Upon repeat analysis the results are correct. Patients could be affected as described below: (1) False high RBC and HCT may result in a delay of treatment, or the delivery of
Root causePending
ActionThe firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated February 23, 2011 with an enclosed customer response form to all customers who have the affected instruments via US Postal Service (in US). The letter described the product, problem and actions to be taken. The customers were instructed not to analyze specimens using the Autoloader. Instead, analyze their samples uncapped (open vial) using the Manual (Stat) Mode. The end of this notice includes a Quick Reference for Running Manual Samples. For more detailed instructions, please refer to your instrument's Instructions
Quantity1,211 units
DistributionWorldwide distribution: USA (nationwide) and countries of: Angola Mexico Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kong, India, Italy, Mexico, Netherlands, New Zealand, Nigeria, Palestinian, Puerto Rico, Romania, Russi
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030291COULTER ACT 5DIFF AUTOLOADER (AL)
Beckman Coulter, Inc., Apr 17, 2003