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U.S. Department of Health and Human Services

Class 2 Device Recall Coulter Preplus 2

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  Class 2 Device Recall Coulter Preplus 2 see related information
Date Initiated by Firm January 18, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on September 02, 2014
Recall Number Z-1895-2011
Recall Event ID 57948
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
Product Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting system.

PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. The PrepPlus 2 is a compact, fully automated sample work station which can be programmed to perform a wide variety of liquid handling operations where volumes required range from 5 uL to 1000 uL.
Code Information Part #378600
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact
714-993-5321
Manufacturer Reason
for Recall		 The recall was initiated after erroneous, though potentially credible, results due to intermittent reagent level sense failures could be generated. During these failures, the instrument fails to produce a warning that a reagent vial is low or out of reagent. The low or absent levels of reagent used during these failures may lead to insufficient antibody being dispensed into a daughter tube there
FDA Determined
Cause 2		 Other
Action The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated January 18, 2011 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1) Follow PrepPlus 2 Instructions for Use (Part # 4277264-BA) for all reagent and specimen requirements prior to initiating a run on the PrepPlus 2 including: A) Ensuring all dead volume requirements for reagents as indicated in 7.11 and 7.12 of the Sample Processing sections and 12.2 of the Troubleshooting Guide. Appropriate volume of reagent in all vials per the planned number of tests to be run must contain at least the volume listed on the Worklist (plus an additional 10% of the full volume of the container to account for dead volume)". B) Ensuring specimen processing dead volume requirements are met as indicated in section B of Specimen Tube Size to ensure the minimum amount of specimen needed. C) Monitoring for any foaming/bubble accumulation in the reagent vial. 2) A review of all clinically relevant results generated from samples prepared on the system be conducted. Abnormally dim or unexpected negative sample staining patterns should be reviewed to ensure correlation with clinical symptomatology and other diagnostic data. If the clinical information Is in accordance with the clinical data released, the validity of the results could be considered accurate and no retrospective action may be needed. If inconsistent data is observed, please adhere to good laboratory practices within your institution and consider data re-analysis and re-testing. The customers were also instructed to share this information with their laboratory staff and retain it as part of their laboratory Quality System documentation; if they have forwarded any of the affected product(s) listed above to another laboratory, provide a copy of the letter to them, and complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM via fax to: (786)639-7500/7501/750
Quantity in Commerce 369 units (140 in the U.S.)
Distribution Worldwide distribution: USA and countries including: Australia, Barbados, Belarus, Belgium, Canada, Croatia, France, Germany, Ireland, Italy, Japan, Malawi, Mozambique, Namibia, Poland, Puerto Rico, Russian Federation, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Ukraine, United Kingdom, Zambia.
Total Product Life Cycle TPLC Device Report
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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