FDA Device recall Z-1421-2020
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
- FDA Device
- Class II
- ongoing
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 by Siemens Healthcare Diagnostics, citing some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1421-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-01-12 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Reason
Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.
Identifiers
| code_info | Lots N1521417 N1522218 N1528917 N1526418 N1502518 N1527518 N1503218 N1529618 N1503918 N1530318 N1504618 N1531018…Lots N1521417 N1522218 N1528917 N1526418 N1502518 N1527518 N1503218 N1529618 N1503918 N1530318 N1504618 N1531018 N1516318 N1531618 N1517218 N1532318 N1518318 N1535518 N1519418 N1536318 N1520118 ***new lots added 3/2/2020*** N1500119 N1520519 N1500219 N1521319 N1500620 N1522419 N1501119 N1523319 N1501520 N1526719 N1503519 N1527619 N1505619 N1528719 N1506419 N1529619 N1507919 N1533819 N1508519 N1534719 N1510619 N1535719 N1519019 N1530419 N1519719 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1421-2020%22
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