FDA Device recall Z-1384-2017
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162,…
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162,… by Beckman Coulter, citing the probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1384-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-30 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips
Reason
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
Identifiers
| code_info | Serial Number V01257 V02416 V02619 V01444 V02906 V02959 V03934, V03933 V02027, V02022, V04322 V03288 V03314…Serial Number V01257 V02416 V02619 V01444 V02906 V02959 V03934, V03933 V02027, V02022, V04322 V03288 V03314 V02330 V02326 V02329 V02642 V02323 V03571 V03428 V02909, V01251 V01115 V02081 V02248 V03575 V03854 V03403 V04387 V04388, V01406 V01556 V04328 V04390, V01557 V04141 V02103 V01214 V04227, V02438 v01838 V04284 V02535 V02534 V02449 V04312 V02538 V02635 V02530 V02450 V02634 V02485 V02436 V02614 V02463 V02652 V02502 V02536 V02464 V02423 V02435 V02432 V02649 V02459 V02537 V03883 V01689 V03409, V03413 V01753, V01754 V02243 V02985 V02242 V03976 V03851 V03925 V04369 V02026 V03848 V01404 V02430 V03565 V02234 V02373 V01829 V02446 V02703 V01429 V02949 V02899 V04309 V01318 V01546 V04257 V03566 V01548 V01547, V02753 V01541 V01542 V02369, V03922 V01555 V02181 V02070 V01762 V04357 V04350 V04349 V04356 V04291 V01720 V03834 V02335 V03798 V01911 V01998 V03567 V04258 V03238 V04329 V03327 V |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1384-2017%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.