FDA Device recall Z-0843-2020
iChem VELOCITY Urine Chemistry Analyzer
- FDA Device
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of iChem VELOCITY Urine Chemistry Analyzer by Beckman Coulter, citing beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry sy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0843-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-07 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
iChem VELOCITY Urine Chemistry Analyzer
Reason
Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.
Identifiers
| code_info | All serial numbers and SW versions V01257 V02416 V01444 V02619 V02959 V03933 V03934 V02022 V02027 V04322 C…All serial numbers and SW versions V01257 V02416 V01444 V02619 V02959 V03933 V03934 V02022 V02027 V04322 CV04002 V03288 CV04113 V04236 V03472 V04250 V02367 V02287 V01134 V03796 V02453 V03186 V02317 V04256 V03114 V01360 V01655 V02065 V04528 CV04005 V02330 V02323 V02329 V02326 V04511 V02642 V03571 V03428 V02909 V01251 V01115 V02081 V02248 V03575 CV04036 V03403 V04388 V04387 V04389 V04328 V04390 V04141 CV04076 V01214 V04227 V02438 V02449 V02485 V02423 V02432 V02614 v01838 V02649 V02502 V02652 V02464 V02634 V02635 V02450 V02534 V02436 V02536 V02459 V04312 V02530 V02463 V02535 V02435 V04284 CV04083 CV04047 CV04084 V03409 V03413 V01689 V01753 V01754 V03854 V03722 V04753 V02243 V02242 V03851 V03925 V04369 V02026 CV04165 V03848 V04540 V04516 V04515 V01404 V02430 V03565 V04706 V01335 V02234 V02373 V02892 V01829 V02446 V01188 V02782 V03456 V01429 V02021 V02020 V02966 V02949 V |
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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-0843-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.