Food and Medical Device Recalls

Date:9/3/2021

Official Message No.:110860-9-3-2021-PHIN

Contact Info:

Attachments: No

Please review the following message from Alan Talarsky, Environmental Scientist 4, Public Health and Food Protection Program, NJDOH regarding the following Class 1 Recalls issued by the U.S. Food and Drug Administration: 1. Weis Markets today announced it has issued a recall for its in-store $7 Crab Cake Meal for not declaring milk as an allergen on its label. Food allergies are an immune system reaction that occurs soon after eating a food containing an allergen. Even a tiny amount of the allergy-causing food can trigger signs and symptoms such as digestive problems, hives or swollen airways. In some people, a food allergy can cause severe symptoms or even a life-threatening reaction known as anaphylaxis. The product is in a 3-compartment container sold in the deli. This recall is being issued as a precaution. The sell by dates affected are 8/25/2021 through 9/05/2021. The issue was discovered during a routine inspection. Customers may return the product for a full refund. This product was sold in 15 Weis Markets’ stores and their addresses are: 339 W. Walnut St. Shamokin, PA 305 River Avenue Williamsport, PA 7848 Wise Avenue Dundak, MD 2065 Springwood Road York, PA 199 Thomas Johnson Drive Frederick, MD 4126 East Jappa Road Baltimore, MD 4300 Linglestown Road Linglestown, PA 2205 Hanover Pike Hampstead, MD 2045 State Route 57 Hackettstown, NJ 1321 Blue Valley Drive Pen Argyl, PA 9400 Scott Moore Way Perry Hall, MD 6 Milbrook Plaza Mill Hall, PA 1290 Front Street Binghamton, PA 25 West Germantown Pike Norristown, PA 400 Enterprise Circle Martinsburg, WV There have been no reports of allergic reactions related to the consumption of this product to date. Other than the listed stores, no other Weis Markets’ store is included in this recall. Customers seeking additional information can call 1-(866) 999-9347, option 5. Mon-Fri, 8am to 5pm EST. ************************************************************************************* 2. Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced its wholly owned subsidiary, Magellan Diagnostics, Inc. (“Magellan”), expanded the Class I recall of its LeadCare® II Blood Lead Test Kits, LeadCare Plus® Blood Lead Test Kits, and LeadCare Ultra® Blood Lead Test Kits (the “LeadCare Test Kits”) for the detection of lead in whole blood. Magellan provides two controls in the test kits which are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range. Results of the control tests within the acceptable range indicate that the system is operating properly before testing patient samples. In May 2021, Magellan initiated this voluntary recall after identifying an ongoing issue with testing of the controls included in the LeadCare Test Kits. Magellan continues to investigate this issue and has conducted extensive testing to evaluate potential root causes. Scope of Recall Magellan received reports that control tests of either the “Low-Control” (e.g., the “Level 1” control at approximately 9 g/dL ± 3g/dL) and/or the “High-Control” (e.g., the “Level 2” control at approximately 28 g/dL ± 4g/dL) generated a “low” result (i.e., “Control Out of Range-Low” [“COOR-L”]). Magellan initiated the recall because the impacted LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples. As part of the recall to the user level, Magellan is notifying customers and distributors affected by the recall. Magellan's customer recall notification provides instructions for the return and replacement of the impacted LeadCare Test Kits (see list of affected lot numbers below). Catalog No. Product Lot Number Expiration Date 70-6762 LeadCare® II Blood Lead Test Kit 2012M sub-lots*** Apr 8, 2022 2013M* Apr 22, 2022 2014M* Apr 29, 2022 2015M* May 12, 2022 2016M* May 19, 2022 2017M* Jun 10, 2022 2018M Jun 6, 2022 2101M** Jul 28, 2022 2102M Sept 30, 2021 2103M** Aug 18, 2022 2105M** Sep 11, 2022 2106M** Jan 21, 2022 2107M** Sept 30, 2022 2109M Oct 15, 2022 2110M Oct 29, 2022 2111M May 31, 2022 2112M Nov 13, 2022 2113M Jun 30, 2022 2114M Dec 17, 2022 7114M Dec 17, 2022 2115M Dec 29, 2022 82-0004 70-8098 LeadCare Plus® Blood Lead Test Kit LeadCare Ultra® Blood Lead Test Kit 2011MU* Mar 25, 2022 2104MU** Aug 25, 2022 2108MU** Mar 31, 2022 * Lots previously included in the recall initiated on May 7, 2021 ** Lots previously included in the recall initiated on June 11, 2021 *** Only the following sub-lots of lot 2012M are included in the recall: -08, -09, -10, -11, -12, -13, and -14 Magellan recommends the following: • Customers should discontinue use of all LeadCare Test Kits lots identified as part of the recall and quarantine remaining inventory. • Distributors should stop distribution of all LeadCare Test Kits lots identified as part of the recall, review current inventory and quarantine any remaining stock. • Health Care Providers should evaluate patient test results that were generated with all recalled lots. 1. Suspect results should be confirmed with an alternative lead testing option, such as those using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) at a high complexity, CLIA-certified, reference laboratory. 2. See CDC’s recommended actions based on blood lead level: https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm • Promptly complete and return the Customer Notification Form in the Urgent Medical Device Recall letter to LeadCareSupport@magellandx.com or FAX to (978) 600-1480. Complete this form even if you have no remaining inventory. These forms are also available on Magellan’s COOR-L recall webpage: https://www.magellandx.com/resources/leadcare-test-kit-controls-out-of-range-low-coor-lo-recall/ • After the form has been submitted, contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan and receive replacement product when available. Product distribution has been paused until further notice and replacement product is currently unavailable. Magellan continues to investigate the root cause of the COOR-LO failure mode and is working diligently to find a solution to resume shipments/replacements as quickly as possible. If you have questions about this recall, please contact Magellan’s LeadCare® Product Support Team at 1-800-275-0102, or email at LeadCareSupport@magellandx.com. The U.S. Food and Drug Administration (“FDA”) has been notified of this recall. FDA MedWatch Reporting Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. • Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Contact: Charlie Wood Vice President – Investor Relations Meridian Bioscience, Inc. Phone: +1 513.271.3700 Email: mbi@meridianbioscience.com ________________________________________ Company Contact Information Consumers: Magellan’s LeadCare® Product Support Team 1-800-275-0102 LeadCareSupport@magellandx.com ****************************************************************************** No action is required of local health departments at this time for either of these recalls. If any requests for assistance are received from FDA, the Public Health and Food Protection Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below. ****************************************************************************** For all recalls - http://www.recalls.gov/recent.html