Reported Nov 27, 2024 · Ongoing
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step
- Siemens Material Number(SMN)11099326 All lots starting with N15 or 15 are expected to have the defect
- Lot codes and dates
23 of 23 products
Products covered by this recall # Barcodes Product as published 1 00630414596143Lot # UDI N1527024 (01)00630414596143(10)N1527024(17)20291002 2 00630414596143N1526424 (01)00630414596143(10)N1526424(17)20291001 3 00630414596143N1525924 (01)00630414596143(10)N1525924(17)20290924 4 00630414596143N1525324 (01)00630414596143(10)N1525324(17)20290918 5 00630414596143N1524224 (01)00630414596143(10)N1524224(17)20290911 6 00630414596143N1523724 (01)00630414596143(10)N1523724(17)20290904 7 00630414596143N1523024 (01)00630414596143(10)N1523024(17)20290827 8 00630414596143N1521824 (01)00630414596143(10)N1521824(17)20290814 9 00630414596143N1521424 (01)00630414596143(10)N1521424(17)20290808 10 00630414596143N1519324 (01)00630414596143(10)N1519324(17)20290719 11 00630414596143N1518924 (01)00630414596143(10)N1518924(17)20290716 12 00630414596143N1518224 (01)00630414596143(10)N1518224(17)20290710 13 00630414596143N1518324 (01)00630414596143(10)N1518324(17)20290710 14 00630414596143N1516224 (01)00630414596143(10)N1516224(17)20290621 15 00630414596143N1515624 (01)00630414596143(10)N1515624(17)20290612 16 00630414596143N1514924 (01)00630414596143(10)N1514924(17)20290605 17 00630414596143N1514124 (01)00630414596143(10)N1514124(17)20290530 18 00630414596143N1513324 (01)00630414596143(10)N1513324(17)20290522 19 00630414596143N1512824 (01)00630414596143(10)N1512824(17)20290515 20 00630414596143N1512424 (01)00630414596143(10)N1512424(17)20290510 - Amount recalled
- 9729 units
Where it was sold
- Nationwide
Why it was recalled
A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.
This product could cause temporary or reversible health problems — stop using it.
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