Alerta De Seguridad para Verify 2 - REGISTER NUMBER: 10158120436, Lot # 161901 - Expiry date: October 2005, Lot # 161888 - Expiry date: October 2006, Lot # 1003551 - Expiry date: February 2007 .. Verify 3 REGISTRATION NUMBER: 10158120552 - Lot nº 161910 - Expiry date: October 2006 and Lot nº 161893 - Validity date: February 2007

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

In conclusion, there is a definite trend of the instrument between the Thrombolyzer and Option instruments. The% PT values ​​assigned to Verify 2 and Verify 3 are to be labeled in the Option having a normal set (3.2 to 4.6%) or CPO (3.3 to 4.7% PT ) as calibrator. Recovery of% PT values ​​also depends on the CPO lot used. A difference of about 0 to 4% PT was observed depending on the CPO lot used to create the curve. The root cause of customer complaints is a combination of several factors: - Designation of% PT target values ​​only in the instrument MAX. It is the main contributing factor based on the data collected in this study. - Designation of% PT target values ​​using a normal set as the sole calibrator. The normal set is prepared internally with a limited number of donors and minimal characterization. No cross-checks are done when batches are changed. Caliplasma Quick is not used as a calibrator in the designation procedure. - The designation of% PT values ​​for Caliplasma calibrators does not include a reference batch of Caliplasma Quick or a well-characterized batch in the labeling process. This will reduce batch variability in Caliplasma Quick lots and improve recovery of Verify target values. CORRECTIVE ACTIONS: Short Term: Based on the consistent trend seen between Option and MAX instruments, Option customers will receive correction factors for Verify 2 and Verify 3 when using Simplastin Excel or Excel S. This will be an intermediate solution, since it solves only the trend factor of the instrument and not the contribution of the calibrator used in the labeling process to the Verify controls. Correction factors were based on data collected from 3 lots of each reagent (Simplastin Excel and Excel S), 2 to 3 lots each of Verify 2 and Verify 3, one batch of GSNPP and 3 lots of CPQ. The correlation coefficients were very good, R = 0.99 for both Simplastin Excel and Simplastin Excel S. Long Term: Qualify a new reference batch of GSNPP for the labeling of both the Verify and CPQ controls. This set will come from a well-reputed source with a minimum of 40 well-characterized donors. Cross-sectional studies will be conducted to qualify new lots of GSNPP. Include a CPQ reference batch in the CPQ test batch labeling. Validate a new procedure to include tests in the Option instrument using both CPQ and GSNPP as calibrators. At least 2 different CPQ lots will be included in the validation. Determine whether you need to provide specific MAX OPTION and OPTION OPTION values ​​for the Verify controls. Include verification tests for the MAX and Option instruments for target values ​​of the Verify control. BioMerieux Brasil has not received any complaints regarding this matter. Note: If your laboratory uses any of these product batch (s), it recommends: - Take the immediate actions of exchange of the tables of reference values ​​for the table (s) with revised values ​​(crof)