Device product
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.
Z-1937-2019
Product summary
- Event
- Event 82879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 956,798/100 test strip vials
- Official record key
device-enforcement:Z-1937-2019
Official wording
Reason: Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
Code information: Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.
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.
Derived failure modes
-
Unknown
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.