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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results

AUDIENCE: Pediatrics, Risk Manager, Laboratory, Family Medicine

ISSUE: The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the CDC to identify the cause and better characterize the extent of the problem. At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples. The FDA is aggressively investigating the root cause of this issue with the manufacturers, health care facilities and the CDC, and will update this safety communication as critical information becomes available. For more information please refer to the Safety Communication.

BACKGROUND: Magellan Diagnostics Inc. manufactures the following lead testing systems affected by this warning: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra.

The LeadCare Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous). This warning applies to all four Magellan Diagnostics LeadCare Testing Systems when processing venous blood samples, in the United States.

Note: Magellan’s LeadCare II is a point-of-care (CLIA-waived) blood lead testing system on which users mostly test capillary blood samples. However, some laboratories also process venous blood samples with the LeadCare II system, which is why this safety communication includes all Magellan LeadCare Testing Systems.

The LeadCare Testing Systems are used in clinical laboratories, doctor’s offices, clinics, and hospitals throughout the U.S.

RECOMMENDATION: The FDA recommends laboratories and health care professionals take the following actions:

• Discontinue using Magellan’s’ LeadCare System Testing Systems with venous blood samples. At this time, all LeadCare systems can be used with capillary blood samples.
• If laboratories or health care professionals are concerned about using the LeadCare Test Systems, the alternative options are mass spectrometry or atomic absorption methods. These are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs.
• This Safety Communication replaces all previous communication from Magellan Diagnostics on their LeadCare lead testing systems including Magellan’s most recent Field Safety Correction Notification dated April 28, 2017.

The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• 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.

Please see the complete MedWatch Safety Alert at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558988.htmWang GlobalNet Issues Allergy Alert Undeclared Eggs, Wheat In “Fish Cake, Fish Ball, And Fish Tofu”

05/18/2017 11:25 AM EDT

Wang Globalnet of Moonachie, NJ is recalling 5 Cases of Fish Cake (Item#:13125), 2 cases of Fish Ball (Item#: 20072), 186 Cases of Fish Cake (Item#: 12842), 4 Cases of Fish Cake (Item#: 15731), and 3 Cases of Fish Tofu (Item#: 17185) because it may contain undeclared egg and wheat. People who have an allergy or severe sensitivity to eggs and wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin. 

Henning’s Cheese voluntarily recalls Colby Jack cheese

05/17/2017 04:20 PM EDT

Henning’s Cheese located in Kiel, Wisconsin, announced today that it is voluntarily recalling a limited amount of its Colby Jack cheese due to a temporary pasteurizer malfunction. Due to the malfunction, verification of proper pasteurization is not possible. No illnesses have been reported related to consumption of this product and no other Henning’s Cheese products are affected by this recall.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Global Garlic Inc. Recalls Queso Fresco/ Whole Milk Cheese Because Of Possible Health Risk

05/17/2017 04:07 PM EDT

Global Garlic Inc. of Miami, Florida is recalling 227 units of Queso Fresco/ Whole Milk Cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

La Nica Products, Inc. Recalls Cheese Because of Possible Health Risk

05/16/2017 05:07 PM EDT

La Nica Products, Inc. of Miami, FL is recalling six thousand pounds of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

The U.S. Food and Drug Administration (FDA) has warned consumers that certain lead tests manufactured by Magellan Diagnostics may have given inaccurate results. Here's what you need to know: These lead tests may have been given from 2014 to the present. The tests in this warning were given to adults and children and require having blood drawn. The affected tests are called LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra. Here's what you can do: The FDA recommends that children and women who are currently pregnant or nursing who were given these tests be retested immediately. 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