FDA Device recall Z-1937-2019
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial by Beckman Coulter, citing falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1937-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-18 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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.
Reason
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
Identifiers
| code_info | Lot numbers beginning with lot 7212143 except for: 7212146, 7212148, 7212160, 7212162, 7212163 and 7212164. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1937-2019%22
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