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Terminated

The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software

FDA Recall Z-2979-2020 · Posted None

Recalling FirmLife Technologies Corporation
Recall StatusTerminated
Product CodeQJR
Date Initiated2020-08-06
Date Terminated2022-05-05
Product QuantityNA

Reason for Recall

COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.

Firm Action

On 08/06/2020, the firm sent an "Urgent: Medical Device Field Correction" notification to customers via email and a follow-up letter via FedEx informing them of two issues associated with COVID-19 interpretive software: 1) A small number of poorly extracted patient samples were called valid by the interpretive software, related to current MS2 assay analysis settings. This issue can potentially cause a weakly positive sample that is prepared by suboptimal extraction to be falsely called a valid negative sample, thereby constituting a False Negative. And 2) The MS2 assay, which detects the Internal Positive Control (IPC), was erroneously called amplified in a small percentage of Positive Control (PC) samples. This issue caused a plate to be designated invalid, thereby requiring unnecessary retesting of an entire batch of samples. The firm is not requesting return of product. The issue is related to software and improper mixing/vortexing of the qPCR plates. Customer are instructed to: -Notify all Applied Biosystems COVID-19 Interpretive Software users in their facility of this communication. -Stop using Applied Biosystems COVID-19 Interpretive Software v1.2, v2.0 and v2.2. -Go to www.thermofisher.com/educationconnect and sign in with their thermofisher.com username and password. Type in the subscription code C19CKEUAFIS1323 to access and complete the training. The customer will be required to pass an exam and acknowledge that they have reviewed information to upgrade the COVID-19 Interpretive Software. Re-registration is required for this upgrade. For full instructions to learn how to access the new version of the software please read the recalling firm's EducationConnect welcome letter or watch the quick video tutorial. -Read and implement the vortexing recommendations added to the latest release of the Instructions for Use available on the product page TaqPath COVID-19 EUA IFU to prevent insufficient mixing and/or centrifugation. -Sign and return Ac

Root Cause

Other

Distribution Pattern

US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, NV, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. OUS: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Brazil, Cameroon, Canada, Cypress, Estonia, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Mozambique, Namibia, New Zealand, Oman, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, United Republic of Tanzania, and Vietnam.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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