Z-1629-2018 Class II Terminated
FDA device recall Z-1629-2018 was initiated by Abbott Gmbh & Co. KG on December 14, 2017 and is designated Class II. Reason for recall: Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old. The recall status is terminated (terminated October 10, 2018). Affected quantity: 10,153 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- December 14, 2017
- Termination Date
- October 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,153 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution in the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VT, WA, WY. Distributed internationally to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Tajikistan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, Uganda, United Kingdom, Uruguay .