Ellume said tests from those lots … What to Do If You Used an Ellume COVID-19 Home Test – Check if your Home Test is included in the product recall by comparing the lot number on the test carton to the lot numbers on the Ellume website. Compare the lot number to the recalled lot numbers listed in the Medical Device Recall Database Entry. The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume, the first company to get FDA approval for over-the-counter COVID tests, due to "higher-than-acceptable false positive test results." Ellume recalled batches of its at-home coronavirus test kits, which are sold at Amazon, CVS, Target, Walmart, and Everlywell, due to a … That number had … Customers with Ellume COVID-19 home test kits should compare the product lot number on the sticker on the side of the carton with the recalled lot numbers. Customers can find product lot numbers on the sticker on the side of the Ellume COVID-19 Home Test carton. Compare the lot number to the recalled lot numbers listed in the Medical Device Recall Database Entry. DA: 39 PA: 52 MOZ Rank: 16 bulk-pack boxes containing 72 pieces of “SPINACH FETA CHICKEN SLIDERS” with lot codes 2361 or 2631 represented on the label. Ellume Issues “Serious” Recall Of 2 Million Plus Home COVID Tests. The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume due to "higher-than-acceptable false positive test results." Compare the lot number to the recalled lot numbers listed in the Medical Device Recall Database Entry. Customers can find product lot numbers on the sticker on the side of the Ellume COVID-19 Home Test carton. Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots. Lot numbers are posted on a sticker on the side of the Ellume tests. 10/04/2021: Lab Alert: Ellume Issues Voluntary Recall of Specific Lots of Ellume COVID-19 Home Tests. On Thursday, the Food and Drug Administration announced a voluntary recall on 2.2 million at-home COVID-19 tests made by manufacturer Ellume, which was the first …
(CNN) - More than 2 million at-home COVID-19 tests are being recalled due to a high number of false positive results. Ellume will inform customers who used an affected test and received a positive result. Nov. 12. FDA has recalled 2 million units of Ellume COVID19 Home Test. Affected tests purchased by consumers but not yet used will be disabled via a software update. Ellume said it has identified the root cause of the issue and is working on resolving it, … The Ellume at-home COVID-19 test which has been voluntarily recalled. Potential for False Positive Results with Certain Lots of fda.gov Customers with Ellume COVID-19 home test kits should compare the product lot number on the sticker on the side of the carton with the recalled lot numbers. Affected tests that are not yet … The … From Food and Drug Administration. Compare the lot number to the recalled lot numbers listed in the Medical Device Recall Database Entry.Affected tests purchased by consumers but not yet used will be disabled via a software update. What to Do If You Used an Ellume COVID-19 Home Test – Check if your Home Test is included in the product recall by comparing the lot number on the test carton to the lot numbers on the Ellume website. Ellume COVID-19 Home Test Voluntary Recall In September 2021, we noted an increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result. Ellume COVID-19 Home Test Code Information Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N … Check the lot numbers of any Ellume kits purchased against the lot numbers on Ellume’s Web site. Affected tests purchased by consumers but not yet used will be disabled via a software update. More than 2 million COVID-19 home tests from Ellume are being recalled due to potential false-positive test results, according to the Food and Drug Administration. Customers with Ellume COVID-19 home test kits should compare the product lot number on the sticker on the side of the carton with the recalled lot numbers. Ellume issues voluntary recall of specific lots of Ellume COVID-19 Home Tests. Ellume will inform customers who used an affected test and received a positive result. Affected tests purchased by consumers but not yet used will be disabled via a software update. Ellume is recalling more than 2 million at-home COVID-19 test kits over concerns of high rates of false positives, the U.S. Food and Drug Administration announced Wednesday.
To see if your Ellume test is one of the recalled lots, locate the product lot numbers on the sticker on the side of the package and then visit the FDA website to find the catalogue and master lot numbers. When the CDC issued new guidance regarding its testing requirement for international travel on May 7, there was a collective sigh of relief as travelers hoped that entering the United States from Test users have been told to compare the lot number on the test carton to the lot numbers on Ellume’s website. Customers can find product lot numbers on the sticker on the side of the Ellume COVID-19 Home Test carton. Customers with Ellume COVID-19 home test kits should compare the product lot number on the sticker on the side of the carton to the recalled lot numbers. Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots. The Ellume recall was initiated after higher numbers of false-positive results were reported about the test than were observed during laboratory development. CBS News said the label with the lot number is attached to the side of the product box. The company said about 427,000 tests are in the lots identified in the recall, and nearly 200,000 are unused. If you have one of these test kits at home, check if it’s part of the recall by comparing the lot number on the test carton to the lot numbers on Ellume’s website.
The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. Anyone who purchased an Ellume test kit at least two weeks ago could be affected by the recall. Ellume COVID-19 Home Test Voluntary Recall In September 2021, we noted an increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result. According to FDA.gov, this recall has been identified as a Class 1 recall which they say is "the most serious type of recall." The recall is an expansion of last month's recall of 200,000 kits for the same issue. The FDA recommends checking to see if your Ellume COVID-19 Home Test is included in Ellume’s product recall by comparing the lot number on the test carton to the lot numbers on Ellume’s website.
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