Z-0721-2021 Class II Ongoing
FDA device recall Z-0721-2021 was initiated by Siemens Healthcare Diagnostics, Inc. on November 23, 2020 and is designated Class II. Reason for recall: Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) li… The recall status is ongoing. Affected quantity: 397 units US; 1713 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 397 units US; 1713 units OUS
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam. ¿¿¿¿ ¿¿¿¿¿