| Class 2 Device Recall 862.2160 Discrete photometric chemistry analyzer | |
Date Initiated by Firm | October 29, 2004 |
Date Posted | December 28, 2004 |
Recall Status1 |
Terminated 3 on March 16, 2005 |
Recall Number | Z-0371-05 |
Recall Event ID |
30395 |
510(K)Number | K023764 |
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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Product | UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). |
Code Information |
Part Number: 386167 Lot Number: 04250160 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
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For Additional Information Contact | Kathleen M. Jaker 714-961-3666 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Other |
Action | 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. |
Quantity in Commerce | 56 boxes |
Distribution | FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JJE
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