Safety Alert for MYLA CLINIC PATCH 3.2. 0 CD; MYLA MASTER DVD 3.2 CLIN DL 380. Series Affected: CZ3506NWES; CZ3236VT9W; CZ3340PEAS; CZ3511512M; CZJ13001PNZ; CZ342682XS; CZ3349VSH6; CZJ2202C36; CZ342682XA; CZJ11900VQ; CZ3339NT8F; CZ3342RW86; CZ3506NWEJ; CZ3340PEAN; CZJ24109F3; CZ3339NT8LCZ3339NT8L; CZ3340PJ7N; CZ3349VSFX; CZC3340PEAR.

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.

The MYLA allows the reuse of a sample ID and / or patient ID to enable alignment of its functionality to the LIS requirements. As part of this feature, an ID (sample or patient) is active in MYLA for a certain period. The "active" status (using that number) is set to 28 days by default. However, it can be configured by the user for a different specific time period. In this time period, if a sample with a patient ID is "active," any result associated with a sample ID received by the MYLA will be compared to find the active sample ID, thus associating the result with the request. Note: The request from the LIS contains the Sample ID, Patient ID, and other demographic information. If no active sample ID is found, MYLA manages this result as an orphan and is sent to the LIS without a patient ID. At the same time, this orphaned result is stored in MYLA to wait for a LIS request that contains this unknown sample ID. The MYLA allows the management of results received from a connected instrument before the corresponding request is sent from the LIS to the MYLA (EX: in case of emergency at night). //// In considering the problem affecting this field action, there is a possibility that results are associated with the incorrect patient and erroneously transferred to the LIS. In the case where erroneous results are delivered to the physician, the impact to the patient will depend on the severity of the infection, the coexisting morbidities, the adequacy of the empirical antibiotic therapy, the need for additional diagnoses or therapeutic intervention. These cases may also lead to the use of inappropriate antibiotics to the patient. Additional details are described in the Customer Letter (attached). ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.