Data Foundry

Medical device recalls 2020

Atellica CH Reaction Ring Segment — Class II medical device recall Z-1421-2020

Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2020-03-11, distributed nationwide. Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to

Recall numberZ-1421-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSiemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States
Recall initiated2020-01-12
Classified2020-03-02
Reported by FDA2020-03-11
DistributedNationwide (US)
Quantity3,559
UPC / GTIN / UDI-DI00630414596143
Lot numbersN1502518, N1503218, N1503918, N1504618, N1516318, N1517218, N1518318, N1519418, N1520118, N1521417, N1522218, N1526418, N1527518, N1528917, N1529618, N1530318, N1531018, N1531618, N1532318, N1535518, N1536318

Product

Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1421-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.