862.2160 Discrete photometric chemistry analyzer 의 리콜

Recall

30395

Class 2

Z-0371-05

2004-10-29

2004-12-28

Terminated

United States

2005-03-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35798

Beckman coulter has confirmed reports of rare occurrences of unicel dxl 800 access immunoassay systems reaction vessels that are deformed or flattened in their packaging bags for lot 04250160. deformed or flattened rvs could present a rish of causing jams on the unicel exl 800 access immunoassay systems that may require service intervention and could compromise sample analysis.

All customers that were shipped lot 042500160 of the reaction vessels were contacted via telephone (or via on-site visit - Canada only) October 29 - November 1, 2004. A Product Correction Action Letter dated November 2,2 004, sent via U.S. mail to all customers, once contacted by phone with fax back forms.