Class 1 Device Recall Draeger Jaundice Meter JM103

• Date Initiated by Firm: May 15, 2018
• Date Posted: June 07, 2018
• Recall Status: Terminated on February 08, 2023
• Recall Number: Z-2046-2018
• Recall Event ID: 79963
• 510(K)Number: K042522
• Product Classification: Bilirubin (total and unbound) in the neonate test system - Product Code MQM
• Product: Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications
• Code Information: All products
• Recalling Firm/ Manufacturer: Draeger Medical Systems, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Dhaval R. Trivedi; 215-721-5400
• Manufacturer Reason for Recall: Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
• FDA Determined Cause: Device Design
• Action: The firm, Drager, sent an "Urgent Medical Device Safety Notices" were distributed to customers on 5/15/18. The letter described the product, problem and actions to be taken. The letters instruct customers to perform the following: Enclosed with this letter are label/s and instructions on how and hwere to apply the label onto your device/s. Please make sure that all JM-105/JM-103 devices in your hospital are labeled according to the instructions in a timely manner. Please make sure that in your clinical environment the users are trained in the use of the equipment and the clinical workflow is set up in a way that the device is not used as a diagnostic device. In case of any uncertainty (e.g. risk factors cannot be evaluated), a blood test needs to be performed. The risk factors according to the Guideline of American Academy of Pediatrics are summarized in the attached Sample Usage Protocol Template as well as the recommended method to use the device as intended in a clinical environment. Please completed and return the attached Customer Reply card. If you have any questions regarding, please call 1-800-437-2437(press 1 at the prompt than 32349) between the hours of 8:00am-4:30pm EST.
• Quantity in Commerce: 10363
• Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Benin, Bolivia, Bosnia-Herz., Botswana, Brazil, British Virgin Islands, Brunei Darussalam, Bulgaria, Burkina-Faso, Cambodia, Canada, Chile, Columbia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Guiana, Macedonia, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nicaragua, Nigeria, Norway, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St Vincent, St Pier Miquel, Sweden, Switzerland, Tadzhikistan, Tanzania, Thailand, Trinidad Tobago, Tunisia, Turkey, Turkmenistan, United Kingdom, Uruguay, UAE, Venezuela, Vietnam, and Zimbabwe.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQM