Z-1937-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- October 18, 2018
- Termination Date
- November 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 956,798/100 test strip vials
Product Description
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
Reason for Recall
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
Distribution Pattern
Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan.
Code Information
Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.