LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be reported to appropriate state/local public health authorities. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The LightMix Zika rRT-PCR Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures. The Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
This recall has been terminated (originally issued November 16, 2016).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- November 16, 2016
- Terminated
- December 12, 2017
- Recall Number
- Z-0750-2017
- Quantity
- 24 pieces
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The LightCycler 480 algorithm used for the LightMix Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is an inflection point in the fluorescence signal.
Distribution
Nationwide Distribution
Lot / Code Info
38161611
Root Cause
Software design
Action Taken
Roche Molecular Diagnostics Inc. sent an Urgent Medical Device Correction Letter dated November 16, 2016, to all affected customers via UPS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product until Roche provides updated Instructions for Use to assist in result interpretation. If product was further distributed, ensure the Urgent Medical Device Correction letter is provided to that site. Also, customers were instructed to completed the attached fax form and fax it to 1-888-912-2188. For questions customers should call 1-800-526-1247.