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Recall Observatory FDA recall evidence

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

October 18, 2018

Class II

Product summary

Firm
Beckman Coulter Inc.
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

    reason.no_named_rule · v1.0.0

    Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.