iChem VELOCITY Urine Chemistry Strips recall
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…
Why was iChem VELOCITY Urine Chemistry Strips recalled?
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164.
- 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…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 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.
- Recall date
- July 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)