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.
Reported: July 10, 2019 Initiated: October 18, 2018 #Z-1937-2019
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 956,798/100 test strip vials
- Distribution
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc.. Units affected: 956,798/100 test strip vials.
Why was this product recalled? ▼
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1937-2019.
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