Retiro De Equipo (Recall) de Device Recall Coulter Preplus 2

Recall

57948

Class 2

Z-1895-2011

2011-01-18

Terminated

United States

2014-09-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97813

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.

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