ADVIA hematology calibrator lots carry incorrect platelet value assignments
ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall of a laboratory calibrator with incorrect assigned values and no clinical consequence stated in the source.
Plain-English summary
The ADVIA 120/2120/2120i SETpoint Calibrator, Siemens Material Number 10312285, UDI 00630414224343, is being recalled. The action covers 2,020 units.
The stated reason is that the products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected lots are SP251033 and SP251043. Distribution was worldwide, including nationwide in the United States and to Argentina, Australia, Brazil, Canada, Chile and other markets.
Laboratories should identify affected stock using the material number, UDI and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- ADVIA¿ 120/2120/2120i SETpoint Calibrator
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,020
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Siemens Material Number 10312285
- UDI: 00630414224343
- 00630414224343
- Lot No. SP251033
- SP251043.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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